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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003091-77 | EudraCT Number | ||
| JAVELIN OVARIAN 200 | Other Identifier | Alias Study Number |
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A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| avelumab | Experimental | Arm A: avelumab alone |
|
| avelumab plus pegylated liposomal doxorubicin (PLD) | Experimental | Arm B: avelumab plus PLD |
|
| PLD | Active Comparator | Arm C: PLD alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| avelumab | Biological | 10 mg/kg will be given as a 1 hour intravenous infusion (IV) every 2 weeks (Q2W) in 4 week cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from the date of randomization to the date of death due to any cause. OS time was summarized by treatment arm using the Kaplan-Meier method. | From randomization until the date of first documented progression or date of deaths from any cause, whichever came first, assessed up to 30 months (based on cutoff date: 19 September 2018). |
| Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | PFS is defined as the time from date of randomization to the date of the first documentation of progression of disease (PD) or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method. PFS based on BICR assessment was evaluated for this endpoint. | From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Based on BICR Assessment | Percentage of participants achieved objective response (OR) based on BICR assessment is presented for this endpoint. OR is defined as a complete response (CR, disappearance of all target lesions) or partial response (PR, >=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met and before the first documentation of disease progression. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response. |
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Inclusion Criteria:
Mandatory tumor biopsy must be performed prior to enrollment for all patients (unless there is a documented clinical contraindication). In addition, availability of archived FFPE tumor tissue should be confirmed. If a patient underwent tumor tissue collection within 3 months prior to enrollment with no intervening treatment, and the sample is provided, then a new de novo tumor biopsy is not required.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates, PC - HAL | Chandler | Arizona | 85224 | United States | ||
| Arizona Oncology Associates, PC - HAL |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37665777 | Derived | Bonaca MP, Moslehi JJ, Ledermann JA, Michelon E, Wei C, Moran M, Monk BJ, Pujade-Lauraine E. Left Ventricular Ejection Fraction in Patients With Ovarian Cancer Treated With Avelumab, Pegylated Liposomal Doxorubicin, or Both. Oncologist. 2023 Oct 3;28(10):e977-e980. doi: 10.1093/oncolo/oyad213. | |
| 37407274 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Data reported based on last participant last visit (LPLV) date (12 July 2022).
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| ID | Title | Description |
|---|---|---|
| FG000 | Avelumab | Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles. |
| FG001 | Avelumab + PLD | Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 4, 2019 | Jun 20, 2023 |
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| PLD | Drug | PLD (Arm B, Arm C) 40 mg/m2 will be given as a 1 hour IV infusion every 4 weeks (Q4W) in 4 week cycles |
|
|
| Tumor assessments as assessed by BICR were conducted at every 8 weeks from screening until documented disease progression (approximately up to 30 months); based on cutoff date: 19 September 2018. |
| ORR Based on Investigator Assessment | Percentage of participants achieved OR based on investigator assessment is presented for this endpoint. OR is defined as a CR (disappearance of all target lesions) or PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. The ORR on each randomized treatment arm were estimated by dividing the number of participants with OR (CR or PR) by number of participants randomized to the respective treatment arm. | Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018. |
| PFS Based on Investigator Assessment According to RECIST Version 1.1 | PFS is defined as the time from date of randomization to the date of the first documentation of PD or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method. | From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018. |
| Duration of Response (DR) Based on BICR Assessment | DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR [disappearance of all target lesions] or PR [>=30% decrease under the baseline of the sum of diameters of all target measurable lesions]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. | Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018. |
| DR Based on Investigator Assessment | DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR [disappearance of all target lesions] or PR [>=30% decrease under the baseline of the sum of diameters of all target measurable lesions]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. | Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018. |
| Disease Control (DC) Rate Based on BICR Assessment | Percentage of participants achieving DC based on BICR assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or stable disease (SD) according to the RECIST version 1.1. | Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018. |
| DC Rate Based on Investigator Assessment | Percentage of participants achieving DC based on investigator assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or SD according to the RECIST version 1.1. | Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; progression of the malignancy under study. Treatment emergent AEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period. | From the time of the first dose of study treatment through a minimum of 30 days + last dose of study treatment, start day of new anti-cancer therapy -1 day (up to 70 months); based on cutoff date: 13 July 2022. |
| Number of Participants With Laboratory Abnormalities | The number of participants with following laboratory abnormalities meeting any of the Grades 1 to 4 classified according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading version 4.03 were summarized: hematology (anemia, lymphocyte count decreased, neutrophil count decreased; and platelet count decreased) and chemistry laboratory tests (creatinine increased; serum amylase increased and lipase increased). | From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018. |
| Change From Baseline in Vital Signs - Blood Pressure | Vital signs included blood pressure and pulse rate. Changes from baseline in sitting diastolic blood pressure (DBP) and systolic blood pressure (SBP) were summarized. | From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018. |
| Change From Baseline in Vital Signs - Pulse Rate | Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized. | From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018. |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | Categorical summarization ECG criteria were as follows: 1) QT interval, QTcB, QTcF and QTcP: increase from baseline >30 ms or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR): change from baseline >=20 bpm and absolute value <=50 bpm or >=120 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS: >= 120 ms. | From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018. |
| Number of Participants With % Left Ventricular Ejection Fraction (LVEF) Decrease From Baseline | LVEF decrease was summarized by multiple-gated acquisition (MUGA)/ echocardiogram (ECHO) parameter. Participants with a LVEF% >=10 points and >= 15 points decrease from baseline during the on-treatment period were summarized. | Screening, Cycle 3 Day 1 (repeated every 2 cycles) to the end of treatment/withdrawal visit, based on cutoff date: 19 September 2018. |
| Number of Participants With PD-L1 Expression for PFS (Based on BICR Assessment) and for OS | PD-L1 expression was assessed by immunohistochemistry. Participants were considered positive for PD-L1 if their baseline tissue sample demonstrated PD-L1 expression on >=1% of tumor cells or >=5% of immune cells. | Biomarkers are measured only at screening. |
| Number of Participants With CD8 Expression for PFS (Based on BICR Assessment) and for OS | Tumor infiltrating CD8 positive (CD8+) T lymphocytes was assessed by immunohistochemistry. Participants were considered positive for CD8 T cells if their baseline tissue sample demonstrated presence of >=1% CD8+ cells across the area of the tumor. | Biomarkers are measured only at screening. |
| Number of Participants With Improved, Stable and Deterioration Based on 10-Point Change for EORTC QLQ-C30 Global QoL | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) is a 30 question survey and includes 5 functional domain subscales, global health status/quality of life, disease/treatment related symptoms, and the perceived financial impact of disease. Higher scores are reflective of a greater presence of symptoms. | Day 1 of Cycle 1, Day 1 of each subsequent cycle, end of treatment/withdrawal visit and the 30, 60 and 90 days safety follow up visits, based on cutoff date: 19 September 2018. |
| Time to Deterioration in Abdominal/GI Symptom Subscale of EORTC QLQ-OV28 | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer 28 (EORTC QLQ-OV28) is a 28 item instrument with 7 functional domain subscales. Time to deterioration was defined as the time from randomization to the first time the participant's score showed a 15-point or higher increase in the score of the abdominal/GI symptom subscale of the EORTC QLQ-OV28. | From Day 1 of Cycle 1 to prior to end of treatment/withdrawal visit, based on cutoff date: 19 September 2018. |
| Change From Baseline in EQ-VAS Score at End of Treatment | The EuroQol- 5 Dimensions- 5 Levels (EQ-5D-5L) questionnaire consists of the EQ-5D-5L descriptive system and a visual analogue scale (the EuroQol-visual analogue scale [EQ-VAS]). The respondent's self-rated health is assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS. | Baseline and end of treatment/withdrawal visit |
| Serum Trough Concentration (Ctrough) For Avelumab Following Cycle 2 Day 1 Pegylated Liposomal Doxorubicin (PLD) Dose | Ctrough was defined as predose concentration during multiple dosing, and can be observed directly from data. | At predose (0 H) on Cycle 2 Day 1 |
| Serum Maximum Concentration (Cmax) For Avelumab Following Cycle 2 Day 1 PLD Dose | Cmax was defined as maximum observed serum concentration, and can be observed directly from data. | At postdose (end of infusion, 1H) on Cycle 2 Day 1 |
| Cmax For Doxorubicin Following Cycle 2 Day 1 PLD Dose | Cmax was defined as maximum observed serum concentration, and can be observed directly from data. | From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose |
| Area Under The Concentration Time Profile From Time Zero to 24 Hours (AUC24) For Doxorubicin Following Cycle 2 Day 1 PLD Dose | AUC24 was defined as area under the concentration time profile from time zero to 24 hours. | From 0 through 24 hours postdose |
| Area Under The Concentration Time Profile From Time Zero to 336 Hours (AUC336) For Doxorubicin Following Cycle 2 Day 1 PLD Dose | AUC336 was defined as area under the concentration time profile from time zero to 336 hours. | From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose |
| Area Under The Concentration Time Profile From Time Zero to The Last Quantifiable Concentration (AUClast) For Doxorubicin Following Cycle 2 Day 1 PLD Dose | AUClast was defined as area under the concentration time profile from time zero to the time of the last quantifiable concentration (Clast). | From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose |
| Number of Participants With Treatment-Boosted Anti-Drug Antibody (ADA) | Treatment-boosted ADA was defined as a positive ADA result at baseline and the titer ≥ 8×baseline titer at least once after treatment with avelumab. | At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab |
| Number of Participants With Treatment-Induced ADA | Treatment-induced ADA was defined as participant who was ADA-negative at baseline and has at least one positive post-baseline ADA result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result. | At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab |
| Number of Participants With Treatment-Induced Neutralizing Antibody (nAb) | Treatment-induced nAb was defined as participant who was not nAb positive at baseline and had at least one positive post-baseline nAb result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result. | At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Arizona Oncology Associates, PC - HAL | Phoenix | Arizona | 85027 | United States |
| Arizona Oncology Associates, PC - HAL | Scottsdale | Arizona | 85258 | United States |
| Arizona Oncology Associates, PC-HAL | Tempe | Arizona | 85284 | United States |
| Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | 85704 | United States |
| Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | 85711 | United States |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States |
| Highlands Oncology Group | Rogers | Arkansas | 72758 | United States |
| University of California, Irvine/UC Irvine Health | Orange | California | 92868 | United States |
| Sansum Clinic | Santa Barbara | California | 93105 | United States |
| Sansum Clinic | Solvang | California | 93463 | United States |
| Rocky Mountain Cancer Centers | Aurora | Colorado | 80012 | United States |
| Rocky Mountain Cancer Centers | Boulder | Colorado | 80303 | United States |
| Rocky Mountain Cancer Centers | Lakewood | Colorado | 80228 | United States |
| Florida Cancer Specialists | Daytona Beach | Florida | 32117 | United States |
| Florida Cancer Specialists | Wellington | Florida | 33414 | United States |
| Florida Cancer Specialists | West Palm Beach | Florida | 33401 | United States |
| Atlanta Gynecologic Oncology | Atlanta | Georgia | 30342 | United States |
| Northside Hospital - Pharmacy | Atlanta | Georgia | 30342 | United States |
| University Gynecologic Oncology | Atlanta | Georgia | 30342 | United States |
| Northwest Georgia Oncology Centers, P.C. | Austell | Georgia | 30106 | United States |
| Northwest Georgia Oncology Centers, P.C. | Carrollton | Georgia | 30117 | United States |
| Northwest Georgia Oncology Centers, P.C. | Cartersville | Georgia | 30121 | United States |
| Northwest Georgia Oncology Centers, P.C. | Douglasville | Georgia | 30134 | United States |
| Northwest Georgia Oncology Centers, P.C. | Marietta | Georgia | 30060 | United States |
| The University of Kansas Clinical Research Center | Fairway | Kansas | 66205 | United States |
| The University of Kansas Cancer Center and Medical Pavilion | Westwood | Kansas | 66205 | United States |
| Norton Cancer Institute, Norton Healthcare Pavilion | Louisville | Kentucky | 40202 | United States |
| Norton Healthcare Pharmacy, Attn: Marlon Baranda, Pharm D | Louisville | Kentucky | 40202 | United States |
| Norton Hospital | Louisville | Kentucky | 40202 | United States |
| Norton Cancer Institute, St. Matthews Campus | Louisville | Kentucky | 40207 | United States |
| Norton Women's and Children's Hospital | Louisville | Kentucky | 40207 | United States |
| Norton Brownsboro Hospital | Louisville | Kentucky | 40241 | United States |
| Norton Cancer Institute, Brownsboro Hospital Campus | Louisville | Kentucky | 40241 | United States |
| Maryland Oncology Hematology, P.A. | Bethesda | Maryland | 20817 | United States |
| Maryland Oncology Hematology, P.A. | Columbia | Maryland | 21044 | United States |
| Maryland Oncology Hematology P.A. | Silver Spring | Maryland | 20902 | United States |
| Maryland Oncology Hematology P.A. | Silver Spring | Maryland | 20904 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| The University of Kansas Cancer Center, CCP - North | Kansas City | Missouri | 64154 | United States |
| Center of Hope at Renown Regional Medical Center | Reno | Nevada | 89502 | United States |
| Southwest GYN Oncology Associates, Inc. | Albuquerque | New Mexico | 87106 | United States |
| University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87106 | United States |
| Hope Women's Cancer Centers | Asheville | North Carolina | 28806 | United States |
| Mission Hospital, Inc. | Asheville | North Carolina | 28806 | United States |
| Novant Health Oncology Specialists | Kernersville | North Carolina | 27284 | United States |
| Novant Health Oncology Specialists | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44106 | United States |
| Fairview Hospital Moll Pavilion Cancer Center | Cleveland | Ohio | 44111 | United States |
| Fairview Hospital Moll Pavilion Pharmacy | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Hillcrest Hospital Hirsch Cancer Center Pharmacy | Mayfield Heights | Ohio | 44124 | United States |
| Hillcrest Hospital | Mayfield Heights | Ohio | 44124 | United States |
| Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | 97401 | United States |
| Investigational Drug Services, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| The University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Tennessee Oncology, PLLC | Dickson | Tennessee | 37055 | United States |
| Tennessee Oncology, PLLC | Franklin | Tennessee | 37067 | United States |
| Tennessee Oncology, PLLC | Gallatin | Tennessee | 37066 | United States |
| Tennessee Oncology, PLLC | Hermitage | Tennessee | 37076 | United States |
| Tennessee Oncology, PLLC | Lebanon | Tennessee | 37090 | United States |
| Tennessee Oncology, PLLC | Murfreesboro | Tennessee | 37129 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | United States |
| The Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37205 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37207 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37211 | United States |
| Tennessee Oncology, PLLC | Shelbyville | Tennessee | 37160 | United States |
| Tennessee Oncology, PLLC | Smyrna | Tennessee | 37167 | United States |
| Texas Oncology-Austin Central | Austin | Texas | 78731 | United States |
| Texas Oncology-South Austin | Austin | Texas | 78745 | United States |
| Texas Oncology - Bedford | Bedford | Texas | 76022 | United States |
| Texas Oncology -Fort Worth Cancer Center | Fort Worth | Texas | 76104 | United States |
| US Oncology Investigational Products Center (IPC) | Irving | Texas | 75063 | United States |
| US Oncology Investigational Products Center | Irving | Texas | 75063 | United States |
| Texas Oncology - San Antonio Medical Center | San Antonio | Texas | 78240 | United States |
| Texas Oncology - The Woodlands, Gynecologic Oncology | The Woodlands | Texas | 77380 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | United States |
| Carilion Clinic Gynecologic Oncology | Roanoke | Virginia | 24016 | United States |
| Carilion Clinic | Roanoke | Virginia | 24016 | United States |
| Froedtert and The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| Epic Pharmacy,Newcastle Private Hospital | New Lambton Heights | New South Wales | 2305 | Australia |
| Newcastle Private Hospital Pty Limited | Newcastle | New South Wales | 2305 | Australia |
| Icon Cancer Care Wesley | Auchenflower | Queensland | 4066 | Australia |
| Rivercity Pharmacy | Auchenflower | Queensland | 4066 | Australia |
| Mater Pharmacy Services | Brisbane | Queensland | 4101 | Australia |
| Icon Cancer Care Chermside | Chermside | Queensland | 4032 | Australia |
| Clinical Research Unit | Herston | Queensland | 4029 | Australia |
| Metro North Hospital and Health Service | Herston | Queensland | 4029 | Australia |
| Oncology Pharmacy | Herston | Queensland | 4029 | Australia |
| Icon Cancer Care | South Brisbane | Queensland | 4101 | Australia |
| Icon Cancer Foundation | South Brisbane | Queensland | 4101 | Australia |
| Mater Cancer Care Centre | South Brisbane | Queensland | 4101 | Australia |
| Icon Cancer Care Southport | Southport | Queensland | 4215 | Australia |
| Cabrini Health Limited | Brighton | Victoria | 3186 | Australia |
| Cabrini Health Limited | Malvern | Victoria | 3144 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Pharmacy Department | Parkville | Victoria | 3052 | Australia |
| The Royal Women's Hospital | Parkville | Victoria | 3052 | Australia |
| Medizinische Universitat Graz, LKH-Univ. Klinikum Graz | Graz | 8036 | Austria |
| Medizinische Universitat Innsbruck | Innsbruck | 6020 | Austria |
| University Hospital Gent | Ghent | EAST Flanders | 9000 | Belgium |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| AZ Groeninge Hospital | Kortrijk | 8500 | Belgium |
| Universitaire Ziekenhuizen Leuven | Leuven | 3000 | Belgium |
| CHU de Liege - Sart Tilman | Liège | 4000 | Belgium |
| Clinique et Maternite Sainte Elisabeth | Namur | 5000 | Belgium |
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior | Kelowna | British Columbia | V1Y5L3 | Canada |
| British Columbia Cancer Agency-Vancouver Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| St. Boniface General Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Health Sciences Centre | Winnipeg | Manitoba | R3A 1R9 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Nova Scotia Health Authority, QEII Health Sciences Centre, Nova Scotia Cancer Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Nova Scotia Health Authority, QEII Health Sciences Centre | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Sunnybrook Research Institute | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| McGill University Health Centre - Glen Site | Montreal | Quebec | H4A 3J1 | Canada |
| Oncology Pharmacy McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
| Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika | Prague | Czech Republic | 120 00 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 779 00 | Czechia |
| Fakultni nemocnice Ostrava | Ostrava-Poruba | 708 52 | Czechia |
| Vseobecna fakultni nemocnice v Praze, Nemocnicni lekarna, | Prague | 120 00 | Czechia |
| Vseobecna fakultni nemocnice v Praze, Neurologicka klinika | Prague | 120 00 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 12851 | Czechia |
| Fakultni nemocnice v Motole | Prague | 150 06 | Czechia |
| Krajska zdravotni a.s., Masarykova nemocnice v Usti nad Labem, o.z | Ústí nad Labem | 401 13 | Czechia |
| Aalborg University Hospital | Aalborg | 9000 | Denmark |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Centre Francois Baclesse | Caen | 14076 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Service de Radiologie | Lyon | 69373 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| Hôpital Européen Georges Pompidou | Paris | 75908 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69310 | France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| Gustave Roussy Cancer Campus | Villejuif | 94805 | France |
| General Hospital of Athens Alexandra | Athens | 11528 | Greece |
| General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Department of Medical Oncology | Athens/New Kifissia | 14564 | Greece |
| Princess Margaret Hospital | Hong Kong | Hong Kong |
| University of Hong Kong | Hong Kong | Hong Kong |
| Orszagos Onkologiai Intezet, Gyogyszertar | Budapest | 1122 | Hungary |
| Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly | Budapest | 1122 | Hungary |
| Debreceni Egyetem Klinikai Gyogyszertar | Debrecen | 4032 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Onkologiai Kozpont | Szolnok | 5000 | Hungary |
| Mater Misericordiae University Hospital | Dublin | Dublin | 7 | Ireland |
| Mater Private Hospital | Dublin | Dublin | Dublin 7 | Ireland |
| St James's Hospital | Dublin | 8 | Ireland |
| Mater Misericoridae University Hospital | Dublin | D7 | Ireland |
| Mater Private Hospital | Dublin | D7 | Ireland |
| Pharmacy Department | Dublin | Ireland |
| St Vincent's University Hospital | Dublin | Ireland |
| University Hospital Waterford | Waterford | Ireland |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Poliambulatorio Specialistico Villa Salute | Manerbio | Brescia | 25025 | Italy |
| Congregazione delle Suore Infermiere dell'Addolorata | Costa Masnaga | Lecco | 23845 | Italy |
| ASST Fatebenefratelli Sacco | Miano | Milano | 20121 | Italy |
| Servizio Sanitario Regionale Emilia-Romagna | Lugo | Ravenna | 48022 | Italy |
| Fondazione del Piemonte per l'Oncologia | Candiolo | Torino | 10060 | Italy |
| Habilita, San Marco Bergamo | Bergamo | 24122 | Italy |
| Humanitas Cliniche Gavazzeni | Bergamo | 24125 | Italy |
| Humanitas, Unita Operativa di Cardiologia 2 | Bergamo | 24125 | Italy |
| Fondazione Poliambulanza Istituto Ospedelario | Brescia | 25124 | Italy |
| Congregazione delle Suore Infermiere dell'Addolorata | Como | 22100 | Italy |
| Fondazione Teresa Camplani | Cremona | 26100 | Italy |
| Regione Lombardia, A O Istituti Ospitalieri di Cremona | Cremona | 26100 | Italy |
| Regione Lombardia, ASST Cremona | Cremona | 26100 | Italy |
| Istituto Europeo di Oncologia | Milan | 20141 | Italy |
| Ambulatorio dott. Francesco Cavanna, Medico Chirurgo | Piacenza | 29121 | Italy |
| Azienda Unita Sanitaria Locale di Piacenza | Piacenza | 29121 | Italy |
| Azienda USL 4 Prato | Prato | 59100 | Italy |
| Azienda USL 4 Toscana Centro | Prato | 59100 | Italy |
| Servizio Sanitario Regionale Emilia-Romagna | Rimini | 47921 | Italy |
| C D C, Sede di Torino Centro | Torino | 10122 | Italy |
| Shikoku Cancer Center | Matsuyama | Ehime | 791-0280 | Japan |
| Ehime University Hospital | Tōon | Ehime | 791-0295 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| Hyogo Cancer Center | Akashi | Hyōgo | 673-8558 | Japan |
| University of Tsukuba Hospital | Tsukuba | Ibaraki | 305-8576 | Japan |
| Tokai University Hospital | Isehara | Kanagawa | 259-1193 | Japan |
| Nippon Medical School Musashikosugi Hospital | Kawasaki | Kanagawa | 211-8533 | Japan |
| Yokohama City University Hospital | Yokohama | Kanagawa | 236-0004 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Saitama Medical University International Medical Center | Hidaka | Saitama | 350-1298 | Japan |
| Saitama Cancer Center | Kita-adachi-gun | Saitama | 362-0806 | Japan |
| National Defense Medical College Hospital | Tokorozawa | Saitama | 359-8513 | Japan |
| Seirei Hamamatsu General Hospital | Hamamatsu | Shizuoka | 430-8558 | Japan |
| Jichi Medical University Hospital | Shimotsuke | Tochigi | 329-0498 | Japan |
| The University of Tokyo Hospital | Bunkyo-ku | Tokyo | 113-8655 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| Kagoshima University Hospital | Kagoshima | 890-8520 | Japan |
| Kagoshima City Hospital | Kagoshima | 890-8760 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Universitair Medisch Centrum Groningen | Groningen | 9713 AP | Netherlands |
| Universitair Medisch Centrum Groningen | Groningen | 9713 GZ | Netherlands |
| LUMC | Leiden | 2333 ZA | Netherlands |
| Maastricht Universitair Medisch Centrum | Maastricht | 6229 HX | Netherlands |
| Department of Obstetrics and Gynecology, Haukeland University Hospital | Bergen | 5021 | Norway |
| Sykehusapoteket i Bergen | Bergen | 5053 | Norway |
| Oslo Universitetssykehus | Oslo | 0379 | Norway |
| Sykehusapoteket Oslo | Oslo | 0379 | Norway |
| Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie, Apteka Szpitalna | Krakow | 31-115 | Poland |
| Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie | Krakow | 31-115 | Poland |
| Wojewodzki Szpital Specjalistyczny w Olsztynie, Apteka Szpitalna | Olsztyn | 10-561 | Poland |
| Wojewodzki Szpital Specjalistyczny w Olsztynie | Olsztyn | 10-561 | Poland |
| Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w | Poznan | 60-569 | Poland |
| Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego | Poznan | 60-569 | Poland |
| SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku, Apteka Szpitalna | Rybnik | 44-200 | Poland |
| SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku | Rybnik | 44-200 | Poland |
| State Budgetary Healthcare Institution "Oncology Center #2" of the Ministry of Healthcare | Sochi | Krasnodarskiy Kray | 354057 | Russia |
| State Budgetary Healthcare Institution Pyatigorsk Oncology Dispensary | Pyatigorsk | Stavropol Kray | 357502 | Russia |
| Evimed Llc | Chelyabinsk | 454048 | Russia |
| State Budgetary Healthcare Institution | Chelyabinsk | 454087 | Russia |
| State Budgetary Healthcare Institution "Clinical oncology dispensary #1" | Krasnodar | 350040 | Russia |
| Federal State Budgetary Institution "Russian Cancer Research Center n.a. N.N. Blokhin" | Moscow | 115478 | Russia |
| State Budgetary Healthcare Institution of Nizhegorogsky region | Nizhny Novgorod | 603081 | Russia |
| State Budgetary Healthcare Institution "Orenburg Regional Clinical Oncological Dispensary" | Orenburg | 460021 | Russia |
| State Budget Institution of Healthcare Saint Petersburg Clinical Scientific - Practice Center | Saint Petersburg | 197758 | Russia |
| State Regional Budgetary Healthcare Institution "Regional clinical oncology dispensary" | Veliky Novgorod | 173016 | Russia |
| National University Hospital | Singapore | 119074 | Singapore |
| National University Hospital | Singapore | 119082 | Singapore |
| National Cancer Centre Singapore Pharmacy | Singapore | 169610 | Singapore |
| National Cancer Centre Singapore | Singapore | 169610 | Singapore |
| Raffles Hospital | Singapore | 188770 | Singapore |
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Clinical Trial Pharmacy, Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System, Clinical Trial Pharmacy | Seoul | 03722 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center Clinical Trial Pharmacy | Seoul | 06351 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Department of Pharamacy, The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| The Catholic University of Korea | Seoul | 06591 | South Korea |
| Institut Catala d'Oncologia - Hospital Duran y Reynalds | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| lnstitut Catala d Oncologia de Girona. Hospital Universitario Dr. Josep Trueta | Girona | 17007 | Spain |
| Hospital MD Anderson | Madrid | 28033 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Centro Integral Oncologico Clara Campal | Madrid | 28050 | Spain |
| Hospital Universitario Virgen de Valme | Seville | 41014 | Spain |
| Universitatsspital Basel, Frauenklinik | Basel | Canton of Basel-City | 4031 | Switzerland |
| Universitatsspital Basel | Basel | Canton of Basel-City | 4031 | Switzerland |
| Luzerner Kantonsspital, Medizinische Onkologie, Studienzentrale Onkologie | Lucerne | Canton of Lucerne | 6000 | Switzerland |
| Oncology Institute of Southern Switzerland (IOSI) | Bellinzona | Canton Ticino | 6500 | Switzerland |
| Kantonsapotheke Zurich | Zurich | 8006 | Switzerland |
| Universitaetsspital Zurich, Klinik fuer Gynakologie | Zurich | 8091 | Switzerland |
| Universitatsspital Zurich, Clinical Trials Center | Zurich | 8091 | Switzerland |
| Universitatsspital Zurich, Institut fur diagnostische und interventionelle Radiologie | Zurich | 8091 | Switzerland |
| Universitatsspital Zurich, Universitares Herzzentrum Zurich | Zurich | 8091 | Switzerland |
| Clinical Trial Pharmacy, National Cheng Kung University Hospital | Tainan | 701 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Clinical Trial Pharmacy, Mackay Memorial Hospital | Taipei | 10449 | Taiwan |
| Mackay Memorial Hospital | Taipei | 104 | Taiwan |
| Clinical Trial Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center | Taipei | 11259 | Taiwan |
| Clinical Trial Pharmacy, Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center | Taipei | 112 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Chang Gung Memorial Hospital - Linkou Branch | Taoyuan City | 333 | Taiwan |
| Chemotherapy Pharmacy, Chang Gung Memorial Hospital - Linkou Branch | Taoyuan City | 333 | Taiwan |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
| Ross Hall Hospital | Glasgow | CITY of Glasgow | G52 3NQ | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Bebington, Wirral | Merseyside | CH63 4JY | United Kingdom |
| The Clatterbridge Cancer Centre | Bebington, Wirral | Merseyside | CH63 4JY | United Kingdom |
| East and North Hertfordshire NHS Trust | Northwood | Middlesex | HA6 2RN | United Kingdom |
| Northampton General Hospital NHS Trust | Northampton | Northamptonshire | NN1 5BD | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Headington | Oxford | OX3 7LE | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Sutton | Surrey | SM2 5PT | United Kingdom |
| Spire Healthcare Limited (St. Anthony's Hospital) | Sutton | Surrey | SM3 9DW | United Kingdom |
| NHS Greater Glasgow and Clyde | Glasgow | G12 0YN | United Kingdom |
| University College London Hospital NHS Foundation Trust | London | NW1 2PG | United Kingdom |
| Guy's & St Thomas' NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| Guy's & St. Thomas' NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| The Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
| Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |
| University College London Hospital NHS Foundation Trust | London | WC1E 6AG | United Kingdom |
| The Christie Hospital NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Nottingham University Hospital NHS Trust | Nottingham | NG5 1PB | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG5 1PB | United Kingdom |
| Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3. |
| 34143970 | Derived | Pujade-Lauraine E, Fujiwara K, Ledermann JA, Oza AM, Kristeleit R, Ray-Coquard IL, Richardson GE, Sessa C, Yonemori K, Banerjee S, Leary A, Tinker AV, Jung KH, Madry R, Park SY, Anderson CK, Zohren F, Stewart RA, Wei C, Dychter SS, Monk BJ. Avelumab alone or in combination with chemotherapy versus chemotherapy alone in platinum-resistant or platinum-refractory ovarian cancer (JAVELIN Ovarian 200): an open-label, three-arm, randomised, phase 3 study. Lancet Oncol. 2021 Jul;22(7):1034-1046. doi: 10.1016/S1470-2045(21)00216-3. Epub 2021 Jun 15. |
| To obtain contact information for a study center near you, click here. | View source |
| FG002 | Pegylated Liposomal Doxorubicin (PLD) | PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles. |
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| Treated | Participants received at least 1 dose of study drug. |
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| COMPLETED | Participants were considered completed when at least one drug of the combination is completed. |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Avelumab | Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles. |
| BG001 | Avelumab + PLD | Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles. |
| BG002 | Pegylated Liposomal Doxorubicin (PLD) | PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival (OS) | OS is defined as the time from the date of randomization to the date of death due to any cause. OS time was summarized by treatment arm using the Kaplan-Meier method. | The primary analyses of OS were performed based on the Full Analysis Set (FAS). The FAS included all participants who were randomized. | Posted | Median | 95% Confidence Interval | months | From randomization until the date of first documented progression or date of deaths from any cause, whichever came first, assessed up to 30 months (based on cutoff date: 19 September 2018). |
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| Primary | Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | PFS is defined as the time from date of randomization to the date of the first documentation of progression of disease (PD) or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method. PFS based on BICR assessment was evaluated for this endpoint. | The primary analyses of PFS based on BICR assessment were performed using FAS. The FAS included all participants who were randomized. | Posted | Median | 95% Confidence Interval | months | From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018. |
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| Secondary | Objective Response Rate (ORR) Based on BICR Assessment | Percentage of participants achieved objective response (OR) based on BICR assessment is presented for this endpoint. OR is defined as a complete response (CR, disappearance of all target lesions) or partial response (PR, >=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met and before the first documentation of disease progression. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response. | The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | Tumor assessments as assessed by BICR were conducted at every 8 weeks from screening until documented disease progression (approximately up to 30 months); based on cutoff date: 19 September 2018. |
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| Secondary | ORR Based on Investigator Assessment | Percentage of participants achieved OR based on investigator assessment is presented for this endpoint. OR is defined as a CR (disappearance of all target lesions) or PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. The ORR on each randomized treatment arm were estimated by dividing the number of participants with OR (CR or PR) by number of participants randomized to the respective treatment arm. | The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018. |
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| Secondary | PFS Based on Investigator Assessment According to RECIST Version 1.1 | PFS is defined as the time from date of randomization to the date of the first documentation of PD or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method. | The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized. | Posted | Median | 95% Confidence Interval | month | From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018. |
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| Secondary | Duration of Response (DR) Based on BICR Assessment | DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR [disappearance of all target lesions] or PR [>=30% decrease under the baseline of the sum of diameters of all target measurable lesions]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. | The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized. Number analyzed are participants with confirmed CR or PR in the FAS within each treatment group. | Posted | Median | 95% Confidence Interval | months | Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018. |
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| Secondary | DR Based on Investigator Assessment | DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR [disappearance of all target lesions] or PR [>=30% decrease under the baseline of the sum of diameters of all target measurable lesions]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. | The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized. Number analyzed are participants with confirmed CR or PR in the FAS within each treatment group. | Posted | Median | 95% Confidence Interval | months | Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018. |
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| Secondary | Disease Control (DC) Rate Based on BICR Assessment | Percentage of participants achieving DC based on BICR assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or stable disease (SD) according to the RECIST version 1.1. | The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018. |
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| Secondary | DC Rate Based on Investigator Assessment | Percentage of participants achieving DC based on investigator assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or SD according to the RECIST version 1.1. | The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018. |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; progression of the malignancy under study. Treatment emergent AEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period. | Analysis is based on the safety analysis set. The safety analysis set included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From the time of the first dose of study treatment through a minimum of 30 days + last dose of study treatment, start day of new anti-cancer therapy -1 day (up to 70 months); based on cutoff date: 13 July 2022. |
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| Secondary | Number of Participants With Laboratory Abnormalities | The number of participants with following laboratory abnormalities meeting any of the Grades 1 to 4 classified according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading version 4.03 were summarized: hematology (anemia, lymphocyte count decreased, neutrophil count decreased; and platelet count decreased) and chemistry laboratory tests (creatinine increased; serum amylase increased and lipase increased). | 'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set who can be evaluated for CTCAE criteria for each parameter in each treatment group. | Posted | Count of Participants | Participants | From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018. |
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| Secondary | Change From Baseline in Vital Signs - Blood Pressure | Vital signs included blood pressure and pulse rate. Changes from baseline in sitting diastolic blood pressure (DBP) and systolic blood pressure (SBP) were summarized. | 'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set with at least a baseline and post-baseline assessment at the visit. | Posted | Mean | Standard Deviation | mm Hg | From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018. |
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| Secondary | Change From Baseline in Vital Signs - Pulse Rate | Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized. | 'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set with at least a baseline and post-baseline assessment at the visit. | Posted | Mean | Standard Deviation | bpm | From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018. |
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| Secondary | Number of Participants With Electrocardiogram (ECG) Abnormalities | Categorical summarization ECG criteria were as follows: 1) QT interval, QTcB, QTcF and QTcP: increase from baseline >30 ms or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR): change from baseline >=20 bpm and absolute value <=50 bpm or >=120 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS: >= 120 ms. | 'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set who had a at least 1 post-baseline ECG assessment performed. | Posted | Count of Participants | Participants | From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018. |
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| Secondary | Number of Participants With % Left Ventricular Ejection Fraction (LVEF) Decrease From Baseline | LVEF decrease was summarized by multiple-gated acquisition (MUGA)/ echocardiogram (ECHO) parameter. Participants with a LVEF% >=10 points and >= 15 points decrease from baseline during the on-treatment period were summarized. | 'Number of Participants Analyzed' is based on number of participants in the safety analysis set with a baseline and a post-baseline assessment within each treatment group. | Posted | Count of Participants | Participants | Screening, Cycle 3 Day 1 (repeated every 2 cycles) to the end of treatment/withdrawal visit, based on cutoff date: 19 September 2018. |
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| Secondary | Number of Participants With PD-L1 Expression for PFS (Based on BICR Assessment) and for OS | PD-L1 expression was assessed by immunohistochemistry. Participants were considered positive for PD-L1 if their baseline tissue sample demonstrated PD-L1 expression on >=1% of tumor cells or >=5% of immune cells. | The biomarker analysis set included participants who had at least 1 screening biomarker assessment. 'Number of Participants Analyzed' is based on number of participants in the biomarker analysis set within each treatment group with reported PD-L1 status. | Posted | Count of Participants | Participants | Biomarkers are measured only at screening. |
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| Secondary | Number of Participants With CD8 Expression for PFS (Based on BICR Assessment) and for OS | Tumor infiltrating CD8 positive (CD8+) T lymphocytes was assessed by immunohistochemistry. Participants were considered positive for CD8 T cells if their baseline tissue sample demonstrated presence of >=1% CD8+ cells across the area of the tumor. | The biomarker analysis set included participants who had at least 1 screening biomarker assessment. 'Number of Participants Analyzed' is based on number of participants in the biomarker analysis set within each treatment group with reported CD8 status. | Posted | Count of Participants | Participants | Biomarkers are measured only at screening. |
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| Secondary | Number of Participants With Improved, Stable and Deterioration Based on 10-Point Change for EORTC QLQ-C30 Global QoL | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) is a 30 question survey and includes 5 functional domain subscales, global health status/quality of life, disease/treatment related symptoms, and the perceived financial impact of disease. Higher scores are reflective of a greater presence of symptoms. | The analysis is based on the FAS. The FAS included all participants who were randomized. 'Number Analyzed' in represents number of participants in the FAS with a score at baseline and post-baseline. | Posted | Count of Participants | Participants | Day 1 of Cycle 1, Day 1 of each subsequent cycle, end of treatment/withdrawal visit and the 30, 60 and 90 days safety follow up visits, based on cutoff date: 19 September 2018. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Deterioration in Abdominal/GI Symptom Subscale of EORTC QLQ-OV28 | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer 28 (EORTC QLQ-OV28) is a 28 item instrument with 7 functional domain subscales. Time to deterioration was defined as the time from randomization to the first time the participant's score showed a 15-point or higher increase in the score of the abdominal/GI symptom subscale of the EORTC QLQ-OV28. | The analysis is based on the FAS. The FAS included all participants who were randomized. | Posted | Median | 95% Confidence Interval | months | From Day 1 of Cycle 1 to prior to end of treatment/withdrawal visit, based on cutoff date: 19 September 2018. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EQ-VAS Score at End of Treatment | The EuroQol- 5 Dimensions- 5 Levels (EQ-5D-5L) questionnaire consists of the EQ-5D-5L descriptive system and a visual analogue scale (the EuroQol-visual analogue scale [EQ-VAS]). The respondent's self-rated health is assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS. | The analysis is based on the FAS. The FAS included all participants who were randomized. 'Number Analyzed' represents number of participants in the FAS with an assessment at the visit or with at least a baseline and post-baseline assessment at visit. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and end of treatment/withdrawal visit |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Trough Concentration (Ctrough) For Avelumab Following Cycle 2 Day 1 Pegylated Liposomal Doxorubicin (PLD) Dose | Ctrough was defined as predose concentration during multiple dosing, and can be observed directly from data. | The PK parameter analysis set was defined as participants in the safety analysis set who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLQ) for avelumab. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (mcg/mL) | At predose (0 H) on Cycle 2 Day 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Maximum Concentration (Cmax) For Avelumab Following Cycle 2 Day 1 PLD Dose | Cmax was defined as maximum observed serum concentration, and can be observed directly from data. | The PK parameter analysis set was defined as participants in the safety analysis set who had at least 1 post-dose concentration measurement above the LLQ for avelumab. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | At postdose (end of infusion, 1H) on Cycle 2 Day 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cmax For Doxorubicin Following Cycle 2 Day 1 PLD Dose | Cmax was defined as maximum observed serum concentration, and can be observed directly from data. | The PK parameter analysis set was defined as a subset of the safety analysis set and included patients who had at least one of the PK parameters of interest for doxorubicin. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under The Concentration Time Profile From Time Zero to 24 Hours (AUC24) For Doxorubicin Following Cycle 2 Day 1 PLD Dose | AUC24 was defined as area under the concentration time profile from time zero to 24 hours. | The PK parameter analysis set was defined as a subset of the safety analysis set and included patients who had at least one of the PK parameters of interest for doxorubicin. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | From 0 through 24 hours postdose |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under The Concentration Time Profile From Time Zero to 336 Hours (AUC336) For Doxorubicin Following Cycle 2 Day 1 PLD Dose | AUC336 was defined as area under the concentration time profile from time zero to 336 hours. | The PK parameter analysis set was defined as a subset of the safety analysis set and included patients who had at least one of the PK parameters of interest for doxorubicin. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under The Concentration Time Profile From Time Zero to The Last Quantifiable Concentration (AUClast) For Doxorubicin Following Cycle 2 Day 1 PLD Dose | AUClast was defined as area under the concentration time profile from time zero to the time of the last quantifiable concentration (Clast). | The PK parameter analysis set was defined as a subset of the safety analysis set and included patients who had at least one of the PK parameters of interest for doxorubicin. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Boosted Anti-Drug Antibody (ADA) | Treatment-boosted ADA was defined as a positive ADA result at baseline and the titer ≥ 8×baseline titer at least once after treatment with avelumab. | The analysis set was defined as participants with valid baseline ADA results and at least one valid post-baseline ADA result in the immunogenicity analysis set. The immunogenicity analysis set was a subset of the safety analysis set and included patients who had at least one ADA/nAb sample collected for avelumab in the avelumab containing arms. | Posted | Count of Participants | Participants | At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Induced ADA | Treatment-induced ADA was defined as participant who was ADA-negative at baseline and has at least one positive post-baseline ADA result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result. | The analysis set was defined as participants with at least 1 valid post-baseline ADA results and without positive baseline ADA result in the immunogenicity analysis set. The immunogenicity analysis set was a subset of the safety analysis set and included patients who had at least one ADA/nAb sample collected for avelumab in the avelumab containing arms. | Posted | Count of Participants | Participants | At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Induced Neutralizing Antibody (nAb) | Treatment-induced nAb was defined as participant who was not nAb positive at baseline and had at least one positive post-baseline nAb result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result. | The analysis set was defined as participants with at least 1 valid post-baseline ADA result and without positive baseline nAb result in the immunogenicity analysis set. The immunogenicity analysis set was a subset of the safety analysis set and included patients who had at least one ADA/nAb sample collected for avelumab in the avelumab containing arms. | Posted | Count of Participants | Participants | At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab |
|
AEs (serious and non-serious) should be reported from the time of the first dose of study treatment through a minimum of 30 days + last dose of study treatment, start day of new anti-cancer therapy -1 day (up to 70 months). Based on the cutoff: 13 July 2022.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. The mortality analysis set included all randomized participants. The AE and SAE analysis set included participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Avelumab | Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles. | 122 | 187 | 72 | 187 | 173 | 187 |
| EG001 | Avelumab + PLD | Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles. | 107 | 182 | 74 | 182 | 176 | 182 |
| EG002 | Pegylated Liposomal Doxorubicin (PLD) | PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles. | 116 | 177 | 51 | 177 | 167 | 177 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Basedow's disease | Endocrine disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Administration site extravasation | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Intestinal pseudo-obstruction | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Malignant gastrointestinal obstruction | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Immune-mediated adverse reaction | Immune system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cholangitis infective | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Lymph gland infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Medical device site infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Septic pulmonary embolism | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Stoma complication | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.0 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Clonic convulsion | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA v25.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Obstructive nephropathy | Renal and urinary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dermatitis exfoliative generalised | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vasculitic ulcer | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Glucocorticoid deficiency | Endocrine disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Device related bacteraemia | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2017 | Sep 9, 2019 | SAP_000.pdf |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000609138 | avelumab |
| C041277 | 1-dodecylpyridoxal |
| D004317 | Doxorubicin |
| C506643 | liposomal doxorubicin |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| American Indian or Alaska Native |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
| Unknown |
|
| 0.2082 |
| Hazard Ratio (HR) |
| 0.89 |
| 2-Sided |
| 95 |
| 0.672 |
| 1.179 |
| Superiority |
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
|
|
|
| OG002 | Pegylated Liposomal Doxorubicin (PLD) | PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles. |
|
|
| Pegylated Liposomal Doxorubicin (PLD) |
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles. |
|
|
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles. |
|
|
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
|
|
|
|
| OG002 | Pegylated Liposomal Doxorubicin (PLD) | PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles. |
|
|
| OG002 |
| Pegylated Liposomal Doxorubicin (PLD) |
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles. |
|
|
|
|
|
|
|
|
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total participants from the 2 arms.
|
|
Total participants from the 2 arms. |
|
|