Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005070-11 | EudraCT Number |
Not provided
Not provided
Business decision not related to patient safety
Not provided
| Name | Class |
|---|---|
| Australia New Zealand Gynaecological Oncology Group | OTHER |
Not provided
Not provided
Not provided
Not provided
The primary objective of the study was to evaluate whether progression-free survival (PFS) was prolonged with the addition of veliparib to standard platinum-based chemotherapy (carboplatin/paclitaxel [C/P]) and continued as maintenance therapy compared with chemotherapy alone.
Participants were randomized in a 1:1:1 ratio to one of three arms. Randomization in the entire population was stratified according to the timing of surgery and residual disease status (any residual disease after primary surgery vs. no residual disease after primary surgery vs. interval surgery) and the paclitaxel schedule (weekly vs. every 3 -weeks), stage of disease (III vs. IV), geographic region (Japan vs. North America and rest of world [ROW]), and germline breast cancer susceptibility gene (BRCA) mutation status (positive versus negative or Unknown).
Cytoreductive surgery could be performed before randomization and the initiation of study treatment (primary) or after 3 cycles of study treatment (interval). The weekly or every-3-week paclitaxel schedule and the choice of primary or interval cytoreductive surgery were determined at the discretion of the investigator.
The primary objective was evaluated in the BRCA-deficient cohort, participants with homologous recombination deficiency (HRD), and the intention-to-treat (ITT) population. These populations were sequentially inclusive, with the HRD population including the BRCA-deficient population, and the ITT population including the HRD and BRCA-deficient populations. The BRCA-deficient population was defined as participants with either a germline (gBRCA) and/or tissue-based (tBRCA) deleterious or suspected deleterious mutation in BRCA1 or BRCA2 confirmed by centralized testing. The HRD population was defined as participants with HRD tumors based on HRD score or presence of a deleterious or suspected deleterious mutation in BRCA1 or BRCA2 as determined by centralized testing.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + Carboplatin + Paclitaxel -> Placebo | Active Comparator | Participants will receive placebo to veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by placebo monotherapy continuous dosing for an additional thirty 21-day cycles. |
|
| Veliparib + Carboplatin + Paclitaxel -> Placebo | Experimental | Participants will receive 150 mg veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by placebo monotherapy continuous dosing for an additional thirty 21-day cycles. |
|
| Veliparib + Carboplatin + Paclitaxel -> Veliparib | Experimental | Participants will receive 150 mg veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by 300/400 mg veliparib monotherapy orally twice a day for an additional thirty 21-day cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veliparib | Drug | Capsules for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1) | PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death prior to the analysis cut-off date, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The analysis of PFS occurred when the protocol-specified number of PFS events was reached. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. | From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. |
| Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1) | PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached and was performed in 3 sequentially inclusive populations. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. . | From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 2 vs Arm 1) | PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death prior to the analysis cut-off date, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The analysis of PFS occurred when the protocol-specified number of PFS events was reached. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham - Main /ID# 138087 | Birmingham | Alabama | 35233 | United States | ||
| Tennessee Valley Gyn-Onc /ID# 139548 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31562800 | Background | Coleman RL, Fleming GF, Brady MF, Swisher EM, Steffensen KD, Friedlander M, Okamoto A, Moore KN, Efrat Ben-Baruch N, Werner TL, Cloven NG, Oaknin A, DiSilvestro PA, Morgan MA, Nam JH, Leath CA 3rd, Nicum S, Hagemann AR, Littell RD, Cella D, Baron-Hay S, Garcia-Donas J, Mizuno M, Bell-McGuinn K, Sullivan DM, Bach BA, Bhattacharya S, Ratajczak CK, Ansell PJ, Dinh MH, Aghajanian C, Bookman MA. Veliparib with First-Line Chemotherapy and as Maintenance Therapy in Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2403-2415. doi: 10.1056/NEJMoa1909707. Epub 2019 Sep 28. | |
| 41565553 |
Not provided
Not provided
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing, please refer to the link below.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Participants were randomized in a 1:1:1 ratio to one of three treatment groups. Randomization was stratified according to the timing of surgery and residual disease after primary surgery or interval surgery, the paclitaxel schedule, stage of disease, geographic region, and germline breast cancer susceptibility gene (BRCA) mutation status.
This trial was conducted at 188 sites in 10 countries (Australia, Brazil, Denmark, Israel, Japan, Poland, Republic of Korea, Spain, United Kingdom, and United States).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Carboplatin + Paclitaxel -> Placebo | Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve (AUC) of 6 milligrams per milliliter per minute (mg/mL/min) every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 8, 2021 | Oct 2, 2024 |
Not provided
Not provided
Not provided
Not provided
| Paclitaxel | Drug | Administered by intravenous infusion, either 80 mg/m² of body-surface area (BSA) on Days 1, 8, and 15 of each 21-day cycle (weekly dosing), or 175 mg/m² of BSA on Day 1 of each 21-day cycle (3-week dosing). |
|
| Carboplatin | Drug | Administered by intravenous infusion at an area under the curve (AUC) of 6 mg/mL/min every 3 weeks. |
|
| Placebo to Veliparib | Other | Capsules for oral administration |
|
| Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1) |
PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death (all causes of mortality) if disease progression was not reached. If the participant did not have an event of disease progression according to RECIST criteria (as or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached. |
| From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. |
| From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. |
| Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 2 vs Arm 1) | PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached and was performed in 3 sequentially inclusive populations. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. . | From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. |
| Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 2 vs Arm 1) | PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death (all causes of mortality) if disease progression was not reached. If the participant did not have an event of disease progression according to RECIST criteria (as or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached. | From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. |
| Overall Survival (OS) in the BRCA-deficient Population | OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive. | From the time of randomization to the end of the study, up to 98 months |
| Overall Survival (OS) in the Homologous Recombination Deficiency Population | OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive. | From the time of randomization to the end of the study, up to 98 months |
| Overall Survival (OS) in the Whole Population | OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive. | From the time of randomization to the end of the study, up to 98 months |
| Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population | The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement. Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease and stage of disease, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate. DRS was not included in the fixed-sequence testing procedure. | Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35 |
| Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population | The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement. Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease and stage of disease, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate. DRS was not included in the fixed-sequence testing procedure. | Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35 |
| Change From Baseline in Disease Related Symptom (DRS) Score in the Whole Population | The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement. Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease, stage of disease, choice of paclitaxel dosing regimen and BRCA-deficient status, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate. DRS was not included in the fixed-sequence testing procedure. | Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35 |
| Huntsville |
| Alabama |
| 35805 |
| United States |
| University of South Alabama /ID# 138091 | Mobile | Alabama | 36604-3302 | United States |
| Alaska Womens Cancer Care /ID# 138231 | Anchorage | Alaska | 99508-4684 | United States |
| Arizona Oncology Associates, PC-HOPE /ID# 142002 | Tucson | Arizona | 85711-2701 | United States |
| Arizona Oncology Associates, PC-HOPE /ID# 143805 | Tucson | Arizona | 85711-2701 | United States |
| Arizona Oncology Associates, PC-HOPE /ID# 143806 | Tucson | Arizona | 85711-2701 | United States |
| Arizona Oncology Associates, PC-HOPE /ID# 143808 | Tucson | Arizona | 85711-2701 | United States |
| University of Arizona Cancer Center - North Campus /ID# 138084 | Tucson | Arizona | 85719-1478 | United States |
| University of Arizona Cancer Center - North Campus /ID# 139495 | Tucson | Arizona | 85719-1478 | United States |
| University of Arkansas for Medical Sciences /ID# 138253 | Little Rock | Arkansas | 72205 | United States |
| John Muir Medical Center /ID# 139618 | Concord | California | 94520 | United States |
| Ucsd /Id# 140323 | La Jolla | California | 92093 | United States |
| Long Beach Memorial Medical Ct /ID# 147526 | Long Beach | California | 90806 | United States |
| Kaiser Permanente /ID# 141305 | Los Angeles | California | 90027 | United States |
| University of California, Los Angeles /ID# 138179 | Los Angeles | California | 90095 | United States |
| Medical Oncology Care Assoc /ID# 139498 | Orange | California | 92868-4304 | United States |
| Univ CA, Irvine Med Ctr /ID# 139613 | Orange | California | 92868 | United States |
| UC Davis Comprehensive Cancer Center - Main /ID# 144439 | Sacramento | California | 95817 | United States |
| California Pacific Medical Ctr /ID# 138177 | San Francisco | California | 94115 | United States |
| Kaiser Permanente - San Francisco /ID# 142051 | San Francisco | California | 94115 | United States |
| Univ California, San Francisco /ID# 138178 | San Francisco | California | 94143-2204 | United States |
| Kaiser Permanente-Santa Clara /ID# 142053 | Santa Clara | California | 95051-5173 | United States |
| Stanford University School of Med /ID# 139450 | Stanford | California | 94305-2200 | United States |
| Palo Alto Medical Foundation /ID# 139452 | Sunnyvale | California | 94086 | United States |
| Kaiser Permanente Medical Ctr-Vallejo /ID# 139492 | Vallejo | California | 94589-2441 | United States |
| Kaiser Permanente- Walnut Creek /ID# 142052 | Walnut Creek | California | 94596 | United States |
| Kaiser Permanente, Waterpark III Institute for Health Research /ID# 139499 | Aurora | Colorado | 80014 | United States |
| Univ of Colorado Cancer Center /ID# 138016 | Aurora | Colorado | 80045 | United States |
| Hartford Healthcare /ID# 138184 | New Britain | Connecticut | 6053 | United States |
| Yale University /ID# 138056 | New Haven | Connecticut | 06510 | United States |
| University of Miami /ID# 139457 | Miami | Florida | 33136 | United States |
| Sarasota Memorial Health Care /ID# 138180 | Sarasota | Florida | 34239 | United States |
| Women's Cancer Associates /ID# 140321 | St. Petersburg | Florida | 33701 | United States |
| Moffitt Cancer Center /ID# 138061 | Tampa | Florida | 33612-9416 | United States |
| Georgia Regents University /ID# 138085 | Augusta | Georgia | 30912 | United States |
| IACT Health /ID# 138058 | Columbus | Georgia | 31904-8946 | United States |
| Memorial Health Univ Med Ctr /ID# 138019 | Savannah | Georgia | 31404 | United States |
| St. Joseph's/Candler /ID# 138090 | Savannah | Georgia | 31405 | United States |
| The Queens Medical Center /ID# 141709 | Honolulu | Hawaii | 96813 | United States |
| Kapiolani Medical Center /ID# 140319 | Honolulu | Hawaii | 96826 | United States |
| Rush University Medical Center /ID# 143491 | Chicago | Illinois | 60612 | United States |
| University of Chicago /ID# 139612 | Chicago | Illinois | 60637-1443 | United States |
| NorthShore University HealthSystem - Evanston Hospital /ID# 139451 | Evanston | Illinois | 60201 | United States |
| Sharma, Hinsdale, IL /ID# 140326 | Hinsdale | Illinois | 60521 | United States |
| Advocate Lutheran General Hosp /ID# 139489 | Park Ridge | Illinois | 60068 | United States |
| Indiana Univ School Medicine /ID# 139610 | Indianapolis | Indiana | 46202 | United States |
| Saint Vincent /ID# 139537 | Indianapolis | Indiana | 46260 | United States |
| McFarland Clinic, PC /ID# 139455 | Ames | Iowa | 50010 | United States |
| University of Iowa Hospitals and Clinics /ID# 138082 | Iowa City | Iowa | 52242 | United States |
| Univ Kansas Med Ctr /ID# 140322 | Kansas City | Kansas | 66160 | United States |
| Baptist Health Lexington /ID# 139542 | Lexington | Kentucky | 40503 | United States |
| University of Kentucky Chandler Medical Center /ID# 138060 | Lexington | Kentucky | 40536 | United States |
| Norton Cancer Institute /ID# 139567 | Louisville | Kentucky | 40202-3700 | United States |
| MMP Women's Health /ID# 139544 | Portland | Maine | 04102 | United States |
| Greater Baltimore Medical Ctr /ID# 138049 | Baltimore | Maryland | 21204 | United States |
| Sinai Hospital of Baltimore /ID# 141306 | Baltimore | Maryland | 21215 | United States |
| Weinberg Cancer Inst Franklin /ID# 138235 | Rossville | Maryland | 21237 | United States |
| Baystate Medical Center /ID# 139456 | Springfield | Massachusetts | 01199 | United States |
| UMass Memorial Medical Center /ID# 139458 | Worcester | Massachusetts | 01655 | United States |
| Wayne State University /ID# 139601 | Detroit | Michigan | 48201-2013 | United States |
| Henry Ford Health System /ID# 139536 | Detroit | Michigan | 48202 | United States |
| William Beaumont Hospital /ID# 139550 | Royal Oak | Michigan | 48073-6710 | United States |
| Mayo Clinic - Rochester /ID# 139565 | Rochester | Minnesota | 55905-0001 | United States |
| Mmcorc /Id# 139534 | Saint Louis Park | Minnesota | 55416 | United States |
| St. Dominic Hospital /ID# 138241 | Jackson | Mississippi | 39216 | United States |
| Ellis Fischel Cancer Center /ID# 139571 | Columbia | Missouri | 65212-1000 | United States |
| Cancer Research For the Ozarks /ID# 139538 | Springfield | Missouri | 65804 | United States |
| Ferrell-Duncan Clinic /ID# 143484 | Springfield | Missouri | 65807 | United States |
| Washington University-School of Medicine /ID# 138089 | St Louis | Missouri | 63110 | United States |
| Nebraska Methodist Hospital /ID# 139600 | Omaha | Nebraska | 68114 | United States |
| Womens Cancer Center of Nevada /ID# 138092 | Las Vegas | Nevada | 89169 | United States |
| Renown Regional Medical Center /ID# 138237 | Reno | Nevada | 89502 | United States |
| Dartmouth-Hitchcock Medical Center /ID# 139502 | Lebanon | New Hampshire | 03756 | United States |
| MD Anderson Cancer Ctr at Coop /ID# 139616 | Camden | New Jersey | 08103 | United States |
| Hackensack Univ Med Ctr /ID# 143776 | Hackensack | New Jersey | 07601 | United States |
| University of New Mexico /ID# 144220 | Albuquerque | New Mexico | 87102 | United States |
| SW Gynecologic Oncology Assoc /ID# 147097 | Albuquerque | New Mexico | 87106 | United States |
| Women's Cancer Care Associates /ID# 138234 | Albany | New York | 12208 | United States |
| SUNY Downstate Medical Center /ID# 139533 | Brooklyn | New York | 11203 | United States |
| Roswell Park Comprehensive Cancer Center /ID# 138052 | Buffalo | New York | 14263 | United States |
| Northwell Health /ID# 139572 | Lake Success | New York | 11042 | United States |
| Icahn School of Med Mt. Sinai /ID# 139617 | New York | New York | 10029 | United States |
| Columbia University Medical Center /ID# 138252 | New York | New York | 10032-3729 | United States |
| Memorial Sloan Kettering Cancer Center /ID# 138017 | New York | New York | 10065-6007 | United States |
| Memorial Sloan Kettering Cancer Center /ID# 154464 | New York | New York | 10065-6007 | United States |
| SUNY Upstate Medical University - Downtown /ID# 139513 | Syracuse | New York | 13210 | United States |
| Montefiore Medical Center /ID# 139585 | The Bronx | New York | 10461 | United States |
| Hope Womens Cancer Centers /ID# 139614 | Asheville | North Carolina | 28816 | United States |
| Univ NC Chapel Hill /ID# 138547 | Chapel Hill | North Carolina | 27514-4220 | United States |
| Atrium Health Carolinas Medical Center /ID# 139568 | Charlotte | North Carolina | 28203 | United States |
| Presbyterian Cancer Center /ID# 139590 | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center /ID# 138048 | Durham | North Carolina | 27710-3000 | United States |
| Wake Forest Baptist Medical Center /ID# 139588 | Winston-Salem | North Carolina | 27157-0001 | United States |
| University of Cincinnati /ID# 139619 | Cincinnati | Ohio | 45267-0585 | United States |
| Univ Hosp Cleveland /ID# 139615 | Cleveland | Ohio | 44106 | United States |
| Fairview Hospital /ID# 144403 | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic Main Campus /ID# 139501 | Cleveland | Ohio | 44195 | United States |
| The Ohio State University - Columbus /ID# 138053 | Columbus | Ohio | 43210 | United States |
| Columbus NCORP /ID# 139587 | Columbus | Ohio | 43215 | United States |
| Womens Cancer Center /ID# 138062 | Kettering | Ohio | 45429-1226 | United States |
| Hillcrest Hospital /ID# 144404 | Mayfield Heights | Ohio | 44124 | United States |
| Univ Oklahoma HSC /ID# 138020 | Oklahoma City | Oklahoma | 73104 | United States |
| Oklahoma Cancer Specialists /ID# 138059 | Tulsa | Oklahoma | 74146 | United States |
| Willamette Valley Cancer Institute /ID# 140318 | Eugene | Oregon | 97401-6043 | United States |
| Kaiser Permanente, NW /ID# 138249 | Portland | Oregon | 97227 | United States |
| Abington Memorial Hospital /ID# 138086 | Abington | Pennsylvania | 19001 | United States |
| University of Pennsylvania /ID# 140079 | Philadelphia | Pennsylvania | 19104-5502 | United States |
| Thomas Jefferson University /ID# 138239 | Philadelphia | Pennsylvania | 19107-4414 | United States |
| Fox Chase Cancer Center /ID# 149479 | Philadelphia | Pennsylvania | 19111 | United States |
| University of Pittsburgh MC /ID# 138054 | Pittsburgh | Pennsylvania | 15260 | United States |
| Reading Hospital /ID# 138057 | Reading | Pennsylvania | 19611 | United States |
| Women and Infants Hospital /ID# 138083 | Providence | Rhode Island | 02905 | United States |
| Medical University of South Carolina /ID# 138181 | Charleston | South Carolina | 29425 | United States |
| Sanford Research/USD /ID# 139624 | Sioux Falls | South Dakota | 57104-8805 | United States |
| Chattanoogas Program in Womens /ID# 139545 | Chattanooga | Tennessee | 37403 | United States |
| Texas Oncology - Austin Central /ID# 143817 | Austin | Texas | 78731 | United States |
| Texas Oncology - South Austin /ID# 143818 | Austin | Texas | 78745 | United States |
| Texas Oncology - Bedford /ID# 143814 | Bedford | Texas | 76022 | United States |
| Texas Oncology - Medical City Dallas /ID# 143809 | Dallas | Texas | 75230 | United States |
| Texas Oncology - Medical City Dallas /ID# 143812 | Dallas | Texas | 75230 | United States |
| Texas Oncology - Forth Worth /ID# 143811 | Fort Worth | Texas | 76104-2150 | United States |
| Houston Methodist Hospital - Scurlock Tower /ID# 138232 | Houston | Texas | 77030 | United States |
| Memorial Hermann Hospital /ID# 138238 | Houston | Texas | 77030 | United States |
| Texas Oncology - The Woodlands /ID# 142003 | The Woodlands | Texas | 77380 | United States |
| Texas Oncology - Tyler /ID# 143810 | Tyler | Texas | 75702 | United States |
| University of Utah /ID# 138250 | Salt Lake City | Utah | 84112-5500 | United States |
| University of Vermont Medical Center /ID# 138251 | Burlington | Vermont | 05401-1473 | United States |
| University of Virginia /ID# 138088 | Charlottesville | Virginia | 22908 | United States |
| Carilion Roanoke Memorial Hosp /ID# 139602 | Roanoke | Virginia | 24014 | United States |
| Skagit Valley Medical Center /ID# 139586 | Mount Vernon | Washington | 98273 | United States |
| MultiCare Regional Cancer Ctr /ID# 149872 | Puyallup | Washington | 93872 | United States |
| Multicare Institute for Research and Innovation /ID# 143485 | Tacoma | Washington | 98405 | United States |
| HSHS St. Vincent Hospital /ID# 139453 | Green Bay | Wisconsin | 54301 | United States |
| Froedtert & the Medical College of Wisconsin /ID# 139449 | Milwaukee | Wisconsin | 53226-3522 | United States |
| Coffs Harbour Health Campus /ID# 145132 | Coffs Harbour | New South Wales | 2450 | Australia |
| Gosford Hospital /ID# 145299 | Gosford | New South Wales | 2250 | Australia |
| St George Hospital /ID# 145138 | Kogarah | New South Wales | 2217 | Australia |
| Newcastle Private Hospital /ID# 145834 | Lambton Heights | New South Wales | 2305 | Australia |
| The Prince of Wales Hospital /ID# 145134 | Randwick | New South Wales | 2031 | Australia |
| Northern Cancer Institute /ID# 145681 | St Leonards | New South Wales | 2065 | Australia |
| Calvary Mater Newcastle /ID# 145139 | Waratah | New South Wales | 2298 | Australia |
| Westmead Hospital /ID# 145137 | Westmead | New South Wales | 2145 | Australia |
| Southern Medical Day Care Ctr /ID# 145133 | Wollongong | New South Wales | 2500 | Australia |
| The Townsville Hospital /ID# 149163 | Douglas | Queensland | 4814 | Australia |
| Royal Brisbane and Women's Hospital /ID# 145135 | Herston | Queensland | 4029 | Australia |
| Icon Cancer Centre /ID# 148208 | South Brisbane | Queensland | 4101 | Australia |
| Mater Misericordiae Limited /ID# 145682 | South Brisbane | Queensland | 4101 | Australia |
| Royal Adelaide Hospital /ID# 150071 | Adelaide | South Australia | 5000 | Australia |
| Monash Health /ID# 145297 | Clayton | Victoria | 3168 | Australia |
| Cabrini Health /ID# 145142 | Malvern | Victoria | 3144 | Australia |
| Royal Womens Hospital /ID# 145136 | Parkville | Victoria | 3052 | Australia |
| Sir Charles Gairdner Hospital /ID# 145140 | Nedlands | Western Australia | 6009 | Australia |
| St. John of God Subiaco Hosp /ID# 147742 | Subiaco | Western Australia | 6008 | Australia |
| Hc Ufmg /Id# 137156 | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| Hospital Sao Lucas da PUCRS /ID# 137157 | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital de Cancer de Barretos /ID# 137121 | Barretos | São Paulo | 14784-400 | Brazil |
| Centro de Referencia da Saude da Mulher - Hospital Perola Byington /ID# 137120 | São Paulo | São Paulo | 01317-000 | Brazil |
| Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 137155 | Rio de Janeiro | 20231-050 | Brazil |
| Vejle Sygehus /ID# 137262 | Vejle | Region Syddanmark | 7100 | Denmark |
| Regionshospitalet Herning /ID# 137260 | Herning | 7400 | Denmark |
| Rambam Health Care Campus /ID# 137434 | Haifa | 3109601 | Israel |
| The Lady Davis Carmel MC /ID# 137537 | Haifa | 3436212 | Israel |
| Shaare Zedek Medical Center /ID# 137435 | Jerusalem | 91031 | Israel |
| Meir Medical Center /ID# 139397 | Kfar Saba | 4428164 | Israel |
| Sheba Medical Center /ID# 137436 | Ramat Gan | 5262100 | Israel |
| Kaplan Medical Center /ID# 137536 | Rehovot | 76100 | Israel |
| Aichi Cancer Center Hospital /ID# 148398 | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Hospital Organization Kyushu Cancer Center /ID# 149133 | Fukuoka | Fukuoka | 811-1395 | Japan |
| Kurume University Hospital /ID# 148697 | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Iwate Medical University Hospital /ID# 147721 | Shiwa-gun | Iwate | 028-3695 | Japan |
| Kumamoto University Hospital /ID# 154169 | Kumamoto | Kumamoto | 860-8556 | Japan |
| Mie University Hospital /ID# 149169 | Tsu | Mie-ken | 514-8507 | Japan |
| Tohoku University Hospital /ID# 149818 | Sendai | Miyagi | 980-8574 | Japan |
| Niigata University Medical & Dental Hospital /ID# 149488 | Niigata | Niigata | 951-8520 | Japan |
| Kindai University Hospital /ID# 154947 | Ōsaka-sayama | Osaka | 5898511 | Japan |
| Shizuoka Cancer Center /ID# 147723 | Sunto-gun | Shizuoka | 411-8777 | Japan |
| The Cancer Institute Hosp JFCR /ID# 148436 | Koto-ku | Tokyo | 135-8550 | Japan |
| Keio University Hospital /ID# 148326 | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Yamagata University Hospital /ID# 153646 | Yamagata | Yamagata | 990-9585 | Japan |
| Hyogo Cancer Center /ID# 148327 | Akashi | 673-8558 | Japan |
| Kansai Rosai Hospital /ID# 149237 | Amagasaki | 660-8511 | Japan |
| The Jikei Univ. Kashiwa Hosp. /ID# 149238 | Kashiwa-shi | 277-0004 | Japan |
| St. Marianna Univ Hospital /ID# 149327 | Kawasaki | 216-8511 | Japan |
| NHO Kure Medical Center and Ch /ID# 148569 | Kure | 737-0023 | Japan |
| Shikoku Cancer Center /ID# 148382 | Matsuyama | 791-0280 | Japan |
| Osaka International Cancer Institute /ID# 150778 | Osaka | 541-8567 | Japan |
| Hokkaido Cancer Center /ID# 148570 | Sapporo | 003-0804 | Japan |
| The Jikei University Hospital /ID# 148691 | Tokyo | 105-8461 | Japan |
| Auckland City Hospital /ID# 145123 | Auckland | 1023 | New Zealand |
| Uniwersyteckie C. Kliniczne /ID# 138021 | Gdansk | 80-214 | Poland |
| National Cancer Center /ID# 139404 | Goyang | Gyeonggido | 10408 | South Korea |
| Korea University Anam Hospital /ID# 136908 | 성북구 | Gyeonggido | 02841 | South Korea |
| Gangnam Severance Hospital /ID# 136835 | Seoul | Seoul Teugbyeolsi | 06273 | South Korea |
| Samsung Medical Center /ID# 136834 | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
| Seoul National University Hospital /ID# 136909 | Seoul | 03080 | South Korea |
| Asan Medical Center /ID# 136836 | Seoul | 05505 | South Korea |
| Hospital Duran i Reynals /ID# 137298 | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Univ Vall d'Hebron /ID# 137297 | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona /ID# 137300 | Barcelona | 08036 | Spain |
| Hospital Clin Univ San Carlos /ID# 137402 | Madrid | 28040 | Spain |
| Hosp Univ 12 de Octubre /ID# 137299 | Madrid | 28041 | Spain |
| Hosp Univ Madrid Sanchinarro /ID# 137414 | Madrid | 28050 | Spain |
| Fundacion Inst Valenciano Onc /ID# 137403 | Valencia | 46009 | Spain |
| Norfolk and Norwich Univ Hosp /ID# 137969 | Norwich | Norfolk | NR4 7UY | United Kingdom |
| Beatson west of scotland cancer center /ID# 137965 | Glasgow | Scotland | G12 0YN | United Kingdom |
| Ninewells Hospital /ID# 137967 | Dundee | DD1 9SY | United Kingdom |
| James Paget University Hosp /ID# 137970 | Great Yarmouth | NR31 6LA | United Kingdom |
| Imanova Limited, Hammersmith Hospital /ID# 137966 | London | W12 0HS | United Kingdom |
| Oxford Univ Hosp NHS Trust /ID# 137973 | Oxford | OX3 7LE | United Kingdom |
| Derived |
| Lafferty J, Secord AA, Bookman M, Coleman RL, Dinh MH, Khandelwal N, Kamalakar R, Cella D. Quality-adjusted progression-free survival analysis of veliparib and carboplatin/paclitaxel compared with chemotherapy alone in patients with newly diagnosed ovarian cancer (VELIA/GOG3005): ancillary analysis of a placebo-controlled, phase 3 randomized trial. Int J Gynecol Cancer. 2026 May;36(5):102819. doi: 10.1016/j.ijgc.2025.102819. Epub 2025 Nov 21. |
| 34906376 | Derived | Swisher EM, Aghajanian C, O'Malley DM, Fleming GF, Kaufmann SH, Levine DA, Birrer MJ, Moore KN, Spirtos NM, Shahin MS, Reid TJ, Friedlander M, Steffensen KD, Okamoto A, Sehgal V, Ansell PJ, Dinh MH, Bookman MA, Coleman RL. Impact of homologous recombination status and responses with veliparib combined with first-line chemotherapy in ovarian cancer in the Phase 3 VELIA/GOG-3005 study. Gynecol Oncol. 2022 Feb;164(2):245-253. doi: 10.1016/j.ygyno.2021.12.003. Epub 2021 Dec 11. |
| 33369580 | Derived | Washington CR, Moore KN. PARP inhibitors in the treatment of ovarian cancer: a review. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):1-6. doi: 10.1097/GCO.0000000000000675. |
| 28665051 | Derived | Nishikawa T, Matsumoto K, Tamura K, Yoshida H, Imai Y, Miyasaka A, Onoe T, Yamaguchi S, Shimizu C, Yonemori K, Shimoi T, Yunokawa M, Xiong H, Nuthalapati S, Hashiba H, Kiriyama T, Leahy T, Komarnitsky P, Fujiwara K. Phase 1 dose-escalation study of single-agent veliparib in Japanese patients with advanced solid tumors. Cancer Sci. 2017 Sep;108(9):1834-1842. doi: 10.1111/cas.13307. Epub 2017 Aug 5. |
| FG001 | Veliparib + Carboplatin + Paclitaxel -> Placebo | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. |
| FG002 | Veliparib + Carboplatin + Paclitaxel -> Veliparib | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The intention-to-treat (ITT) population consisted of all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Carboplatin + Paclitaxel -> Placebo | Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve [AUC] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. |
| BG001 | Veliparib + Carboplatin + Paclitaxel -> Placebo | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. |
| BG002 | Veliparib + Carboplatin + Paclitaxel -> Veliparib | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| Geographic Region | Count of Participants | Participants |
| |||||||||||
| BRCA-Deficient Status | The BRCA-mutation cohort was defined as participants who had deleterious or suspected deleterious germline (gBRCA) or tissue-based (tBRCA) mutations as determined by the Myriad BRACAnalysis® companion diagnostic (CDx) or myChoice® HRD CDx assay, respectively, in BRCA1 or BRCA2. | Count of Participants | Participants |
| ||||||||||
| Homologous Recombination Deficiency (HRD) Status | The HRD cohort consisted of participants who had tumors that were BRCA-mutated or had HRD according to the Myriad myChoice® assay, on which a score of ≥ 33 was considered to indicate HRD status, and a score of < 33 was considered to indicate non-HRD status. | Count of Participants | Participants |
| ||||||||||
| Stage of Disease | Staging of primary ovarian carcinomas according to the International Federation of Gynecology and Obstetrics (FIGO) criteria, based on clinical examination, surgical exploration, histologic characteristics and cytologic testing. STAGE III: Tumor involves 1 or both ovaries with cytologically or histologically confirmed spread to the peritoneum outside the pelvis and/or metastases to the retroperitoneal lymph nodes. STAGE IV: Distant metastases excluding peritoneal metastases | Count of Participants | Participants |
| ||||||||||
| Type of Surgery Received | Cytoreductive surgery could be performed before randomization and the initiation of study treatment (primary) or after 3 cycles of study treatment (interval), determined at the discretion of the investigator. | Count of Participants | Participants |
| ||||||||||
| Residual Disease After Primary Surgery | Data were collected after interval surgery after cycle 3. | Participants who underwent primary surgery | Count of Participants | Participants |
| |||||||||
| Residual Disease After Interval Surgery | Participants who underwent interval surgery | Count of Participants | Participants |
| ||||||||||
| Paclitaxel Dosing Regimen | Count of Participants | Participants |
| |||||||||||
| Germline BRCA Status | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1) | PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death prior to the analysis cut-off date, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The analysis of PFS occurred when the protocol-specified number of PFS events was reached. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. | Analyses were performed in 3 sequentially inclusive populations. The first analysis was conducted using the BRCA-mutation cohort which included participants with either a gBRCA and/or tBRCA deleterious or suspected deleterious mutation in BRCA1 or BRCA2. | Posted | Median | 95% Confidence Interval | months | From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1) | PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached and was performed in 3 sequentially inclusive populations. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. . | Analyses were performed in 3 sequentially inclusive populations. The second analysis was conducted using the HRD cohort which included participants in the BRCA-mutation cohort and those determined to have HRD tumors. | Posted | Median | 95% Confidence Interval | months | From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1) | PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death (all causes of mortality) if disease progression was not reached. If the participant did not have an event of disease progression according to RECIST criteria (as or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached. | Analyses were performed in 3 sequentially inclusive populations. The third analysis was conducted using the intention-to-treat (ITT) population (all randomized participants). | Posted | Median | 95% Confidence Interval | months | From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 2 vs Arm 1) | PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death prior to the analysis cut-off date, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The analysis of PFS occurred when the protocol-specified number of PFS events was reached. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. | Analyses were performed in 3 sequentially inclusive populations. The first analysis was conducted using the BRCA-mutation cohort which included participants with either a gBRCA and/or tBRCA deleterious or suspected deleterious mutation in BRCA1 or BRCA2. | Posted | Median | 95% Confidence Interval | months | From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 2 vs Arm 1) | PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached and was performed in 3 sequentially inclusive populations. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. . | Analyses were performed in 3 sequentially inclusive populations. The second analysis was conducted using the HRD cohort which included participants in the BRCA-mutation cohort and those determined to have HRD tumors. | Posted | Median | 95% Confidence Interval | months | From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 2 vs Arm 1) | PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death (all causes of mortality) if disease progression was not reached. If the participant did not have an event of disease progression according to RECIST criteria (as or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached. | Analyses were performed in 3 sequentially inclusive populations. The third analysis was conducted using the intention-to-treat (ITT) population (all randomized participants). | Posted | Median | 95% Confidence Interval | months | From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) in the BRCA-deficient Population | OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive. | BRCA-Deficient population: All randomized participants with germline and/or tissue deleterious/suspected deleterious BRCA1/2 mutation | Posted | Median | 95% Confidence Interval | months | From the time of randomization to the end of the study, up to 98 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) in the Homologous Recombination Deficiency Population | OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive. | All randomized participants considered BRCA-Deficient and those determined to have HRD tumors based on HRD score | Posted | Median | 95% Confidence Interval | months | From the time of randomization to the end of the study, up to 98 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) in the Whole Population | OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive. | All randomized participants | Posted | Median | 95% Confidence Interval | months | From the time of randomization to the end of the study, up to 98 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population | The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement. Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease and stage of disease, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate. DRS was not included in the fixed-sequence testing procedure. | BRCA-mutation population, participants with available data at each time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population | The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement. Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease and stage of disease, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate. DRS was not included in the fixed-sequence testing procedure. | HRD population, participants with available data at each time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Disease Related Symptom (DRS) Score in the Whole Population | The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement. Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease, stage of disease, choice of paclitaxel dosing regimen and BRCA-deficient status, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate. DRS was not included in the fixed-sequence testing procedure. | All randomized participants with available data at each time point | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35 |
|
All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Not provided
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 | Placebo + Carboplatin + Paclitaxel -> Placebo | Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve (AUC) of 6 milligrams per milliliter per minute (mg/mL/min) every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. | 228 | 375 | 143 | 375 | 369 | 375 |
| EG001 | Veliparib + Carboplatin + Paclitaxel -> Placebo | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. | 234 | 383 | 130 | 383 | 375 | 383 |
| EG002 | Veliparib + Carboplatin + Paclitaxel -> Veliparib | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent\ veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy. | 209 | 382 | 146 | 382 | 376 | 382 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| APLASTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| BONE MARROW FAILURE | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| STRESS CARDIOMYOPATHY | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| VENTRICULAR EXTRASYSTOLES | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ADRENAL INSUFFICIENCY | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPERTHYROIDISM | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ABDOMINAL ADHESIONS | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ABDOMINAL HERNIA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ABDOMINAL INCARCERATED HERNIA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DIVERTICULAR PERFORATION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ENTEROCOLITIS | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| EPIPLOIC APPENDAGITIS | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| GASTRIC VOLVULUS | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HAEMOPERITONEUM | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HIATUS HERNIA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ILEAL PERFORATION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| INTESTINAL PSEUDO-OBSTRUCTION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| INTRA-ABDOMINAL FLUID COLLECTION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| LARGE INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MECHANICAL ILEUS | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| OESOPHAGITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PNEUMOPERITONEUM | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| SMALL INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| SPIGELIAN HERNIA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HERNIA | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| IMPLANT SITE EXTRAVASATION | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| INCARCERATED HERNIA | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PELVIC MASS | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| BILE DUCT STONE | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ABDOMINAL ABSCESS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| ATYPICAL MYCOBACTERIAL INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| BACTEROIDES BACTERAEMIA | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| CATHETER SITE INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COLONIC ABSCESS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| EMPYEMA | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| ENDOCARDITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| ENTEROBACTER INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| ENTEROCOCCAL BACTERAEMIA | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| ENTEROCOLITIS INFECTIOUS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| ESCHERICHIA INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| GROIN ABSCESS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| IMPLANT SITE INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| INFECTED LYMPHOCELE | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| INTERVERTEBRAL DISCITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| KIDNEY INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| LARGE INTESTINE INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| LYMPHANGITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| MENINGITIS CRYPTOCOCCAL | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| NAIL INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| OPHTHALMIC HERPES ZOSTER | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| PELVIC ABSCESS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| PELVIC INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| PERIORBITAL CELLULITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| PERITONEAL ABSCESS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| PERITONITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| PHARYNGITIS STREPTOCOCCAL | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| PHLEBITIS INFECTIVE | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| POST PROCEDURAL INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| POSTOPERATIVE ABSCESS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| SEPTIC EMBOLUS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| SPONTANEOUS BACTERIAL PERITONITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| SUBDIAPHRAGMATIC ABSCESS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| SYSTEMIC CANDIDA | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| ACETABULUM FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| ANASTOMOTIC LEAK | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| CONCUSSION | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| FRACTURED SACRUM | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| GASTROINTESTINAL STOMA COMPLICATION | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| HEAT ILLNESS | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| INCISIONAL HERNIA | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| INTESTINAL ANASTOMOSIS COMPLICATION | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| MULTIPLE INJURIES | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| PROCEDURAL COMPLICATION | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| SKELETAL INJURY | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| SPINAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| THORACIC VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| VAGINAL CUFF DEHISCENCE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| WOUND COMPLICATION | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| WOUND DECOMPOSITION | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| WOUND DEHISCENCE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| SOLUBLE FIBRIN MONOMER COMPLEX INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| MALIGNANT NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| MALIGNANT PLEURAL EFFUSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| MYELODYSPLASTIC SYNDROME | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| OVARIAN CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| CEREBELLAR INFARCTION | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CEREBRAL ARTERY EMBOLISM | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CEREBRAL VENOUS SINUS THROMBOSIS | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPERSOMNIA | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MIGRAINE | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MIGRAINE WITH AURA | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NEURALGIA | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DEVICE BREAKAGE | Product Issues | MedDRA 26.0 | Systematic Assessment |
| |
| DEVICE DISLOCATION | Product Issues | MedDRA 26.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| RENAL INFARCT | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| RENAL VEIN THROMBOSIS | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| URETEROLITHIASIS | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| FEMALE GENITAL TRACT FISTULA | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DYSPNOEA AT REST | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PNEUMONITIS ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PNEUMOTHORAX SPONTANEOUS | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PULMONARY THROMBOSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| JUGULAR VEIN THROMBOSIS | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| LYMPHOCELE | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PHLEBITIS | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| SUBCLAVIAN VEIN THROMBOSIS | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| THROMBOPHLEBITIS | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| VENOUS THROMBOSIS | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NAIL DISCOLOURATION | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 1-800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 4, 2020 | Aug 4, 2020 | SAP_001.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 |
|---|---|
| C521013 | veliparib |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
Not provided
Not provided
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Superiority |
Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints. |
| OG001 | Veliparib + Carboplatin + Paclitaxel -> Placebo | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. |
| OG002 | Veliparib + Carboplatin + Paclitaxel -> Veliparib | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy. |
|
|
|
| OG001 | Veliparib + Carboplatin + Paclitaxel -> Placebo | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. |
| OG002 | Veliparib + Carboplatin + Paclitaxel -> Veliparib | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy. |
|
|
|
| OG001 | Veliparib + Carboplatin + Paclitaxel -> Placebo | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. |
| OG002 | Veliparib + Carboplatin + Paclitaxel -> Veliparib | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy. |
|
|
|
| OG001 | Veliparib + Carboplatin + Paclitaxel -> Placebo | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. |
| OG002 | Veliparib + Carboplatin + Paclitaxel -> Veliparib | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy. |
|
|
|
| OG001 | Veliparib + Carboplatin + Paclitaxel -> Placebo | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. |
| OG002 | Veliparib + Carboplatin + Paclitaxel -> Veliparib | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy. |
|
|
|
| OG002 | Veliparib + Carboplatin + Paclitaxel -> Veliparib | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy. |
|
|
|
| OG002 | Veliparib + Carboplatin + Paclitaxel -> Veliparib | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy. |
|
|
|
| OG002 | Veliparib + Carboplatin + Paclitaxel -> Veliparib | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy. |
|
|
|
| OG001 | Veliparib + Carboplatin + Paclitaxel -> Placebo | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. |
| OG002 | Veliparib + Carboplatin + Paclitaxel -> Veliparib | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy. |
|
|
| OG001 | Veliparib + Carboplatin + Paclitaxel -> Placebo | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. |
| OG002 | Veliparib + Carboplatin + Paclitaxel -> Veliparib | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy. |
|
|
| OG001 | Veliparib + Carboplatin + Paclitaxel -> Placebo | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. |
| OG002 | Veliparib + Carboplatin + Paclitaxel -> Veliparib | Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy. |
|
|