Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-510605-28 | Registry Identifier | CTIS |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| European Network of Gynaecological Oncological Trial Groups (ENGOT) | OTHER |
Not provided
Not provided
Not provided
Not provided
Ovarian cancer is a heterogeneous disease, characterized by complex molecular and genetic changes. The high expression of vascular endothelial growth factor (VEGF) receptor, programmed death receptor ligands 1 (PD-L1) expression, and deoxyribonucleic acid (DNA) damage in ovarian tumors provide several targets for treatment and maintenance of disease response. Given the unmet medical need of participants with advanced or metastatic ovarian cancer, this study design will enable investigators to provide participants with current SOC for ovarian cancer for the duration of the study. This is a global, multicenter, randomized, double-blind, controlled Phase 3 study that will primarily compare the progression-free survival (PFS) for participants receiving dostarlimab with SOC chemotherapy +/- bevacizumab followed by niraparib and dostarlimab maintenance +/- bevacizumab versus participants receiving SOC with chemotherapy followed by niraparib maintenance. This comparison will be investigated in participants of newly diagnosed stage III or IV advanced non-mucinous epithelial ovarian cancer participants and also to compare PFS of all participants with Stage III or IV high-grade non-mucinous epithelial ovarian cancer treated with platinum-based combination therapy, dostarlimab (TSR-042), and niraparib to SOC platinum-based combination therapy. The currently recommended SOC therapy for the first line treatment of Stage III or IV ovarian cancer is the combination of paclitaxel and carboplatin, with or without concurrent and maintenance bevacizumab. Participants will receive SOC during the chemotherapy Run-In period (cycle 1) before randomization to study treatment (cycle 2). Concurrent bevacizumab use must be determined prior to randomization at cycle 2.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving SOC+placebo | Placebo Comparator | Participants in this arm will receive SOC (carboplatin+paclitaxel+/-bevacizumab) in cycle 1 (each cycle is of 21 days) followed by SOC with chemotherapy treatment with dostarlimab placebo from cycles 2 to 6 and maintenance treatment of +/-bevacizumab along with niraparib placebo and dostarlimab placebo |
|
| Participants receiving SOC+niraparib | Active Comparator | Participants in this arm will receive SOC in cycle 1 (each cycle is of 21 days) followed by SOC with chemotherapy treatment dostarlimab placebo from cycles 2 to 6 and maintenance treatment of +/- bevacizumab with niraparib and dostarlimab placebo |
|
| Participants receiving SOC+dostarlimab+niraparib | Experimental | Participants in this arm will receive SOC in cycle 1 (each cycle is of 21 days) followed by SOC with chemotherapy treatment dostarlimab, and maintenance treatment of +/-bevacizumab with niraparib and dostarlimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib | Drug | Participants will receive oral capsules of niraparib as a unit dosage strength of 100 milligrams (mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documented progressive disease (PD) or death due to any cause, whichever occurs first by the Investigator assessment according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeter (mm). | Up to approximately 316 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival (OS) is defined as the time from the date of randomization to the date of death by any cause. | Up to approximately 316 weeks |
| PFS Determined by Blinded Independent Central Review (BICR) Per RECIST v1.1 Criteria |
Not provided
Inclusion criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Anchorage | Alaska | 99508 | United States | ||
| GSK Investigational Site |
GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf.
Not provided
Not provided
Not provided
Not provided
The results presented are based on primary completion date. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Participants | Eligible participants with ovarian cancer received standard of care (SOC) chemotherapy as combination of 175 milligram (mg)/meter^2(m^2) Paclitaxel, area under the curve (AUC) of 5 to 6 mg/millilitre (mL)/minute Carboplatin and optional 7.5 mg/kilogram (kg) or 15 mg/kg Bevacizumab as intravenous (IV) infusion on Day 1 of Cycle 1 in Chemotherapy Run-In Period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Chemotherapy Run-In Period (Cycle 1) |
|
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 | Aug 8, 2025 | Oct 29, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Dostarlimab (TSR-042) | Drug | Participants will receive 500 mg dostarlimab on day 1 every 3 weeks from cycle 2 to 6 followed by 1000mg of dostarlimab on day 1 every 6 weeks to continue up to 3 years in the absence of disease progression, unacceptable toxicity, participant withdrawal, or investigator decision |
|
| Standard of care | Drug | Participants will receive SOC that includes paclitaxel 175 milligrams per square meter (mg/m^2) on day 1 every 21 days + carboplatin area under the curve (AUC) of 5 to 6 milligrams per milliliter per minute (mg/mL/min) on day 1 every 21 days +/- bevacizumab 7.5 milligrams per kilograms (mg/kg) every 21 days or 15 mg/kg every 21 days for a total of 15 months. |
|
| Dostarlimab-Placebo | Drug | Participants will receive 500 mg of dostarlimab-placebo on day 1 every 3 weeks from cycle 2 to 6 followed by 1000 mg of dostarlimab-placebo on day 1 every 6 weeks to continue up to 3 years in the absence of disease progression, unacceptable toxicity, participant withdrawal, or investigator decision |
|
| Niraparib-Placebo | Drug | Participants will receive oral capsules of niraparib-placebo as a unit dosage strength of 100 mg. |
|
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documented progressive disease (PD) or death due to any cause, whichever occurs first determined by the BICR according to RECIST version 1.1. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
| Up to approximately 316 weeks |
| Time to First Subsequent Therapy (TFST) | Time to First Subsequent Therapy (TFST) is defined as the time from randomization until the start date of the first subsequent anticancer therapy or death by any cause, whichever occurs first. First subsequent anticancer therapy is defined as the earliest anticancer therapy on the follow-up anticancer therapy form. | Up to approximately 316 weeks |
| Time to Second Subsequent Therapy (TSST) | Time to Second Subsequent Therapy (TSST) is defined as the time from the date of randomization to the start date of the second subsequent anticancer therapy or death of any cause, whichever occurs first. Second subsequent anticancer therapy is defined as an anticancer therapy with a start date after the first subsequent anticancer therapy and a recorded PD on first subsequent anticancer therapy, as captured on the follow-up anticancer therapy eCRF form. | Up to approximately 316 weeks |
| Time to Second Progression (PFS2) | PFS2 is defined as the time from the date of randomization to the date of first Progressive Disease per Investigator's assessment after initiation of subsequent anticancer therapy or death due to any cause, whichever occurs first. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeter (mm). | Up to approximately 316 weeks |
| Objective Response Rate (ORR) | Objective Response Rate (ORR) is defined as the percentage of participants with measurable disease at baseline achieving a best overall response (BOR) of complete response (CR) or partial response (PR) by Investigator assessment per RECIST v1.1 criteria for participants with measurable disease at baseline. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. | Up to approximately 316 weeks |
| Duration of Response (DOR) | DOR is defined as the time from the first documented response (complete response (CR) OR partial response (PR) ) to the first documented disease progression per Investigator assessed RECIST v1.1 or death by any cause in participants with measurable disease at baseline who responded to treatment. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. | Up to approximately 316 weeks |
| Disease Control Rate (DCR) | Disease Control Rate (DCR) is defined as the percentage of participants with measurable disease at baseline achieving a best overall response (BOR) of complete response (CR), partial response (PR) or stable disease (SD) by Investigator assessment per RECIST v1.1 criteria for participants with measurable disease at baseline. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR is defined as the disappearance of all target lesions. SD defined as any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. | Up to approximately 316 weeks |
| Number of Participants With Treatment Emergent Positive Antidrug Antibodies (ADAs) of Dostarlimab | Serum samples were collected for the analysis of Anti-drug antibody (ADAs) of dostarlimab. | Up to approximately 316 weeks |
| Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire | EQ-5D-5L is a standardized, participant-rated health outcomes questionnaire covering five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each of dimensions, participant self-assigned score: 1 (no problems); 2 (slight problems); 3 (moderate problems); 4 (severe problems); 5 (extreme problems). VAS is collected separately and recorded from 0 (Worst imaginable health state) to 100 (Best imaginable health state). HUI values summarize how good or bad each health state is on a scale of 1 (full health) to 0 (worse health/dead). High HUI value indicates a good HRQoL. Baseline is defined as the latest, non-missing collected value, excluding end of treatment, safety follow-up, long term follow-up visits records and unscheduled visits after end of treatment (EOT). | Day1 of Chemo Cycles 2(baseline), 4&6; Day1 of Maintenance Cycles 1,2,3,6,9,12,15,17,23,29,35,41,47,53,59,65,71,77,83,89; EOT visit up to a maximum of 63 months; LTFU visit up to a maximum of 69 months(including SFU visit up to a maximum of 61 months) |
| Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30) | The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning [PF], role functioning [RF], cognitive functioning [CF], emotional functioning [EF] and social functioning [SF]), three symptom scales (fatigue, pain and nausea/vomiting [N/V]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. | Day1 of Chemo Cycles 2(baseline), 4&6; Day1 of Maintenance Cycles 1,2,3,6,9,12,15,17,23,29,35,41,47,53,59,65,71,77,83,89; EOT visit up to a maximum of 63 months; LTFU visit up to a maximum of 69 months(including SFU visit up to a maximum of 61 months) |
| Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire | The EORTC QLQ-OV28 supplements the QLQ-C30. It includes three functional scales (body image (BI), sexuality (S), attitude to disease/treatment(ATD)) and five symptom scales/items (abdominal/GI symptoms (AS), peripheral neuropathy (PN), hormonal/menopausal symptoms (MS), other chemotherapy side effects (CSE), and hair loss (HS)). Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much). Higher scores represent better functioning (better quality of life). For functional scales: improved (worsened) is defined as >=10 points increase (decrease) from baseline. For symptom scales: improved (worsened) is defined as >=10 points decrease (increase) from baseline. Baseline is defined as the latest, non-missing collected value, excluding end of treatment, safety follow-up, long term follow-up visits records and unscheduled visits after end of treatment. | Day1 of Chemo Cycles 2(baseline), 4&6; Day1 of Maintenance Cycles 1,2,3,6,9,12,15,17,23,29,35,41,47,53,59,65,71,77,83,89; EOT visit up to a maximum of 63 months; LTFU visit up to a maximum of 69 months(including SFU visit up to a maximum of 61 months) |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| GSK Investigational Site | Tucson | Arizona | 85711 | United States |
| GSK Investigational Site | Los Angeles | California | 90027 | United States |
| GSK Investigational Site | Los Angeles | California | 90048 | United States |
| GSK Investigational Site | Newport Beach | California | 92663 | United States |
| GSK Investigational Site | Farmington | Connecticut | 06030 | United States |
| GSK Investigational Site | Hartford | Connecticut | 06102 | United States |
| GSK Investigational Site | Gainesville | Florida | 32608 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32256 | United States |
| GSK Investigational Site | Geneva | Illinois | 60555 | United States |
| GSK Investigational Site | Warrenville | Illinois | 60555 | United States |
| GSK Investigational Site | Zion | Illinois | 60099 | United States |
| GSK Investigational Site | Covington | Louisiana | 70433 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70121 | United States |
| GSK Investigational Site | Shreveport | Louisiana | 71103 | United States |
| GSK Investigational Site | Scarborough | Maine | 04074 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21201 | United States |
| GSK Investigational Site | Silver Spring | Maryland | 20910 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02215 | United States |
| GSK Investigational Site | Springfield | Massachusetts | 01199 | United States |
| GSK Investigational Site | Worcester | Massachusetts | 01605 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55404 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55455 | United States |
| GSK Investigational Site | Billings | Montana | 59101 | United States |
| GSK Investigational Site | Neptune City | New Jersey | 07753 | United States |
| GSK Investigational Site | Teaneck | New Jersey | 07666 | United States |
| GSK Investigational Site | Hawthorne | New York | 10532 | United States |
| GSK Investigational Site | New York | New York | 10016 | United States |
| GSK Investigational Site | New York | New York | 10029 | United States |
| GSK Investigational Site | New York | New York | 10065 | United States |
| GSK Investigational Site | Rochester | New York | 14620-4159 | United States |
| GSK Investigational Site | Stony Brook | New York | 11794 | United States |
| GSK Investigational Site | Syracuse | New York | 13210 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28204 | United States |
| GSK Investigational Site | Canton | Ohio | 44710 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45219 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| GSK Investigational Site | Eugene | Oregon | 97401 | United States |
| GSK Investigational Site | Portland | Oregon | 97227 | United States |
| GSK Investigational Site | Paoli | Pennsylvania | 19301 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19111 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15224 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15232 | United States |
| GSK Investigational Site | Willow Grove | Pennsylvania | 19001-3788 | United States |
| GSK Investigational Site | Wynnewood | Pennsylvania | 19096 | United States |
| GSK Investigational Site | Providence | Rhode Island | 02905 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29425 | United States |
| GSK Investigational Site | Sioux Falls | South Dakota | 57105 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37920 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37205 | United States |
| GSK Investigational Site | Austin | Texas | 78731 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76104 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | San Antonio | Texas | 78240 | United States |
| GSK Investigational Site | The Woodlands | Texas | 77380 | United States |
| GSK Investigational Site | Tyler | Texas | 75702 | United States |
| GSK Investigational Site | Ogden | Utah | 84405 | United States |
| GSK Investigational Site | Charlottesville | Virginia | 22903 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23502 | United States |
| GSK Investigational Site | Kennewick | Washington | 99336 | United States |
| GSK Investigational Site | Seattle | Washington | 98104 | United States |
| GSK Investigational Site | Seattle | Washington | 98109 | United States |
| GSK Investigational Site | Minsk | 223040 | Belarus |
| GSK Investigational Site | Brasschaat | 2930 | Belgium |
| GSK Investigational Site | Bruges | 8000 | Belgium |
| GSK Investigational Site | Vancouver | British Columbia | V5Z 4E6 | Canada |
| GSK Investigational Site | London | Ontario | N6A 4L6 | Canada |
| GSK Investigational Site | Toronto | Ontario | M4N 3M5 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2X 3E4 | Canada |
| GSK Investigational Site | Montreal | Quebec | H4A 3J1 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 5N4 | Canada |
| GSK Investigational Site | Windsor | 1000 | Canada |
| GSK Investigational Site | Prague | 128 51 | Czechia |
| GSK Investigational Site | Prague | 180 81 | Czechia |
| GSK Investigational Site | Copenhagen | DK- 2100 | Denmark |
| GSK Investigational Site | Herlev | 2730 | Denmark |
| GSK Investigational Site | Roskilde | 4000 | Denmark |
| GSK Investigational Site | Helsinki | 00029 | Finland |
| GSK Investigational Site | Kuopio | 70210 | Finland |
| GSK Investigational Site | Tampere | 33520 | Finland |
| GSK Investigational Site | Turku | 20520 | Finland |
| GSK Investigational Site | Angers | 49055 | France |
| GSK Investigational Site | Avignon | 84918 | France |
| GSK Investigational Site | Besançon | 25030 | France |
| GSK Investigational Site | Bordeaux | 33000 | France |
| GSK Investigational Site | Bron | 69495 | France |
| GSK Investigational Site | Caen | 14000 | France |
| GSK Investigational Site | Cholet | 69373 | France |
| GSK Investigational Site | Clermont-Ferrand | 63011 | France |
| GSK Investigational Site | Dijon | 21079 | France |
| GSK Investigational Site | Grenoble | 38000 | France |
| GSK Investigational Site | Grenoble | 38700 | France |
| GSK Investigational Site | Le Mans | 72000 | France |
| GSK Investigational Site | Lille | 59000 | France |
| GSK Investigational Site | Lyon | 69008 | France |
| GSK Investigational Site | Lyon | 69373 | France |
| GSK Investigational Site | Lyon | 69495 | France |
| GSK Investigational Site | Marseille | 13273 | France |
| GSK Investigational Site | Montpellier | 34070 | France |
| GSK Investigational Site | Montpellier | 34298 | France |
| GSK Investigational Site | Nancy | 54100 | France |
| GSK Investigational Site | Nantes | 44227 | France |
| GSK Investigational Site | Nice | 06189 | France |
| GSK Investigational Site | Nîmes | 30029 | France |
| GSK Investigational Site | Paris | 75014 | France |
| GSK Investigational Site | Paris | 75020 | France |
| GSK Investigational Site | Paris | 75248 | France |
| GSK Investigational Site | Paris | 75908 | France |
| GSK Investigational Site | Paris | 75970 | France |
| GSK Investigational Site | Pierre-Bénite | 69495 | France |
| GSK Investigational Site | Plerin-sur-mer | 22190 | France |
| GSK Investigational Site | Poitiers | 86021 | France |
| GSK Investigational Site | Reims | 51056 | France |
| GSK Investigational Site | Rennes | 35042 | France |
| GSK Investigational Site | Saint-Cloud | 75248 | France |
| GSK Investigational Site | Saint-Priest-en-Jarez | 42271 | France |
| GSK Investigational Site | Strasbourg | 67091 | France |
| GSK Investigational Site | Toulouse | 31059 | France |
| GSK Investigational Site | Tours | 37044 | France |
| GSK Investigational Site | Villejuif | 94805 | France |
| GSK Investigational Site | Berlin | 13125 | Germany |
| GSK Investigational Site | Hamburg | 22457 | Germany |
| GSK Investigational Site | Kiel | 24103 | Germany |
| GSK Investigational Site | Münster | 48149 | Germany |
| GSK Investigational Site | Ravensburg | 88212 | Germany |
| GSK Investigational Site | Wolfsburg | 38440 | Germany |
| GSK Investigational Site | Athens | 115 28 | Greece |
| GSK Investigational Site | Athens | 11528 | Greece |
| GSK Investigational Site | Athens | 12462 | Greece |
| GSK Investigational Site | Haidari - Athens | 12462 | Greece |
| GSK Investigational Site | Marousi | 15123 | Greece |
| GSK Investigational Site | Beersheba | 8410101 | Israel |
| GSK Investigational Site | Haifa | 3109601 | Israel |
| GSK Investigational Site | Haifa | 3436212 | Israel |
| GSK Investigational Site | Holon | 5822012 | Israel |
| GSK Investigational Site | Petah Tikva | 4941492 | Israel |
| GSK Investigational Site | Rehovot | 76100 | Israel |
| GSK Investigational Site | Bologna | 40138 | Italy |
| GSK Investigational Site | Faenza | 48018 | Italy |
| GSK Investigational Site | Lugo RA | 48018 | Italy |
| GSK Investigational Site | Meldola FC | 47014 | Italy |
| GSK Investigational Site | Naples | 80131 | Italy |
| GSK Investigational Site | Amsterdam | 1081 HV | Netherlands |
| GSK Investigational Site | Groningen | 9700 RB | Netherlands |
| GSK Investigational Site | Maastricht | 6229 HX | Netherlands |
| GSK Investigational Site | Nijmegen | 6525 GA | Netherlands |
| GSK Investigational Site | Rotterdam | 3015 GD | Netherlands |
| GSK Investigational Site | Utrecht | 3584 CX | Netherlands |
| GSK Investigational Site | Kristiansand | 4632 | Norway |
| GSK Investigational Site | Oslo | 0310 | Norway |
| GSK Investigational Site | Tromsø | 9019 | Norway |
| GSK Investigational Site | Olsztyn | 10-228 | Poland |
| GSK Investigational Site | Szczecin | 70-111 | Poland |
| GSK Investigational Site | Warsaw | 02-781 | Poland |
| GSK Investigational Site | Bucharest | 022328 | Romania |
| GSK Investigational Site | Cluj-Napoca | 400015 | Romania |
| GSK Investigational Site | Cluj-Napoca | 400051 | Romania |
| GSK Investigational Site | Constanța | 900591 | Romania |
| GSK Investigational Site | Craiova | 200347 | Romania |
| GSK Investigational Site | Timișoara | 300239 | Romania |
| GSK Investigational Site | Ávila | 05071 | Spain |
| GSK Investigational Site | Badalona | 08916 | Spain |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Girona | 17007 | Spain |
| GSK Investigational Site | Jaén | 23007 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Madrid | 28702 | Spain |
| GSK Investigational Site | Santiago de Compostela | 15706 | Spain |
| GSK Investigational Site | Toledo | 45007 | Spain |
| GSK Investigational Site | Valencia | 46010 | Spain |
| GSK Investigational Site | Zaragoza | 50009 | Spain |
| GSK Investigational Site | Chernihiv | 14029 | Ukraine |
| GSK Investigational Site | Kharkiv | 61024 | Ukraine |
| GSK Investigational Site | Lviv | 79031 | Ukraine |
| GSK Investigational Site | Glasgow | G12 0YN | United Kingdom |
| GSK Investigational Site | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| GSK Investigational Site | Portsmouth | PO6 3LY | United Kingdom |
| GSK Investigational Site | Sutton | SM2 5PT | United Kingdom |
| GSK Investigational Site | Truro | TR1 3LJ | United Kingdom |
| FG001 | Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib Pbo+Dostarlimab Pbo +/-Bev (Arm1) | Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab placebo (Pbo) on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles starting with Cycle 2, with optional Bevacizumab (Bev) as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib placebo Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision |
| FG002 | Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2) | Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision |
| FG003 | Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3) | Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Chemo Treatment Period (Cycle 2 to 6) |
|
|
| Maintenance Period (Cycle 7 to 89) |
|
|
All eligible enrolled participants received SOC during the Cycle 1 Chemotherapy Run-In Period before randomization.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Participants | Eligible participants with ovarian cancer received standard of care (SOC) chemotherapy as combination of 175 milligram (mg)/meter^2(m^2) Paclitaxel, area under the curve (AUC) of 5 to 6 mg/millilitre (mL)/minute Carboplatin and optional 7.5 mg/kilogram (kg) or 15 mg/kg Bevacizumab as intravenous (IV) infusion on Day 1 of Cycle 1 in Chemotherapy Run-In Period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | YEARS |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | 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) | Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documented progressive disease (PD) or death due to any cause, whichever occurs first by the Investigator assessment according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeter (mm). | The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 316 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall Survival (OS) is defined as the time from the date of randomization to the date of death by any cause. | The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 316 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS Determined by Blinded Independent Central Review (BICR) Per RECIST v1.1 Criteria | Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documented progressive disease (PD) or death due to any cause, whichever occurs first determined by the BICR according to RECIST version 1.1. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. | The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 316 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Subsequent Therapy (TFST) | Time to First Subsequent Therapy (TFST) is defined as the time from randomization until the start date of the first subsequent anticancer therapy or death by any cause, whichever occurs first. First subsequent anticancer therapy is defined as the earliest anticancer therapy on the follow-up anticancer therapy form. | The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 316 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Second Subsequent Therapy (TSST) | Time to Second Subsequent Therapy (TSST) is defined as the time from the date of randomization to the start date of the second subsequent anticancer therapy or death of any cause, whichever occurs first. Second subsequent anticancer therapy is defined as an anticancer therapy with a start date after the first subsequent anticancer therapy and a recorded PD on first subsequent anticancer therapy, as captured on the follow-up anticancer therapy eCRF form. | The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 316 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Second Progression (PFS2) | PFS2 is defined as the time from the date of randomization to the date of first Progressive Disease per Investigator's assessment after initiation of subsequent anticancer therapy or death due to any cause, whichever occurs first. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeter (mm). | The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 316 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | Objective Response Rate (ORR) is defined as the percentage of participants with measurable disease at baseline achieving a best overall response (BOR) of complete response (CR) or partial response (PR) by Investigator assessment per RECIST v1.1 criteria for participants with measurable disease at baseline. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. | The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 316 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR is defined as the time from the first documented response (complete response (CR) OR partial response (PR) ) to the first documented disease progression per Investigator assessed RECIST v1.1 or death by any cause in participants with measurable disease at baseline who responded to treatment. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. | The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 316 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | Disease Control Rate (DCR) is defined as the percentage of participants with measurable disease at baseline achieving a best overall response (BOR) of complete response (CR), partial response (PR) or stable disease (SD) by Investigator assessment per RECIST v1.1 criteria for participants with measurable disease at baseline. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR is defined as the disappearance of all target lesions. SD defined as any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. | The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 316 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Positive Antidrug Antibodies (ADAs) of Dostarlimab | Serum samples were collected for the analysis of Anti-drug antibody (ADAs) of dostarlimab. | Anti-drug antibody (ADA) population included all participants from Arm 3 only who received at least one dose of dostarlimab and who had at least 1 ADA sample with an assay result. | Posted | Count of Participants | Participants | Up to approximately 316 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire | EQ-5D-5L is a standardized, participant-rated health outcomes questionnaire covering five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each of dimensions, participant self-assigned score: 1 (no problems); 2 (slight problems); 3 (moderate problems); 4 (severe problems); 5 (extreme problems). VAS is collected separately and recorded from 0 (Worst imaginable health state) to 100 (Best imaginable health state). HUI values summarize how good or bad each health state is on a scale of 1 (full health) to 0 (worse health/dead). High HUI value indicates a good HRQoL. Baseline is defined as the latest, non-missing collected value, excluding end of treatment, safety follow-up, long term follow-up visits records and unscheduled visits after end of treatment (EOT). | ITT Population.Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3. | Posted | Mean | Standard Deviation | Scores on a scale | Day1 of Chemo Cycles 2(baseline), 4&6; Day1 of Maintenance Cycles 1,2,3,6,9,12,15,17,23,29,35,41,47,53,59,65,71,77,83,89; EOT visit up to a maximum of 63 months; LTFU visit up to a maximum of 69 months(including SFU visit up to a maximum of 61 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30) | The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning [PF], role functioning [RF], cognitive functioning [CF], emotional functioning [EF] and social functioning [SF]), three symptom scales (fatigue, pain and nausea/vomiting [N/V]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. | ITT Population.Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3. | Posted | Count of Participants | Participants | Day1 of Chemo Cycles 2(baseline), 4&6; Day1 of Maintenance Cycles 1,2,3,6,9,12,15,17,23,29,35,41,47,53,59,65,71,77,83,89; EOT visit up to a maximum of 63 months; LTFU visit up to a maximum of 69 months(including SFU visit up to a maximum of 61 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire | The EORTC QLQ-OV28 supplements the QLQ-C30. It includes three functional scales (body image (BI), sexuality (S), attitude to disease/treatment(ATD)) and five symptom scales/items (abdominal/GI symptoms (AS), peripheral neuropathy (PN), hormonal/menopausal symptoms (MS), other chemotherapy side effects (CSE), and hair loss (HS)). Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much). Higher scores represent better functioning (better quality of life). For functional scales: improved (worsened) is defined as >=10 points increase (decrease) from baseline. For symptom scales: improved (worsened) is defined as >=10 points decrease (increase) from baseline. Baseline is defined as the latest, non-missing collected value, excluding end of treatment, safety follow-up, long term follow-up visits records and unscheduled visits after end of treatment. | ITT Population.Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3. | Posted | Count of Participants | Participants | Day1 of Chemo Cycles 2(baseline), 4&6; Day1 of Maintenance Cycles 1,2,3,6,9,12,15,17,23,29,35,41,47,53,59,65,71,77,83,89; EOT visit up to a maximum of 63 months; LTFU visit up to a maximum of 69 months(including SFU visit up to a maximum of 61 months) |
|
All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
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 | Not Treated | Eligible participants with ovarian cancer received standard of care (SOC) chemotherapy as combination of 175 milligram (mg)/meter^2(m^2) Paclitaxel, area under the curve (AUC) of 5 to 6 mg/millilitre (mL)/minute Carboplatin and optional 7.5 mg/kilogram (kg) or 15 mg/kg Bevacizumab as intravenous (IV) infusion on Day 1 of Cycle 1 in Chemotherapy Run-In Period. They were not randomized to chemotherapy treatment period and no study intervention was administered. | 33 | 79 | 35 | 79 | 51 | 79 |
| EG001 | Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib Pbo+Dostarlimab Pbo +/-Bev (Arm1) | Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab placebo (Pbo) on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles starting with Cycle 2, with optional Bevacizumab (Bev) as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib placebo Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision. | 106 | 159 | 63 | 159 | 158 | 159 |
| EG002 | Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2) | Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision. | 235 | 417 | 190 | 417 | 417 | 417 |
| EG003 | Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3) | Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision. | 430 | 745 | 405 | 745 | 745 | 745 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Colonic fistula | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Diaphragmatic hernia | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Gastrointestinal fistula | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hernial eventration | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Immune-mediated gastritis | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Incarcerated umbilical hernia | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Intestinal prolapse | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Oesophagitis ulcerative | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Rectal perforation | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Umbilical hernia, obstructive | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Vasculitis gastrointestinal | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Volvulus of small bowel | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Clostridial sepsis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Device related bacteraemia | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Enterobacter sepsis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Splenic abscess | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Diverticulitis intestinal perforated | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Gastroenteritis shigella | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Haemophilus infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Infected lymphocele | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Infected seroma | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Legionella infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Listeria sepsis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Meningoencephalitis viral | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Nasal abscess | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Post procedural cellulitis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Post procedural sepsis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Stoma site infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Subdiaphragmatic abscess | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Vulvitis | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Aplasia pure red cell | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Acquired amegakaryocytic thrombocytopenia | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Atypical haemolytic uraemic syndrome | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Cytopenia | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Haematotoxicity | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Splenic haematoma | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pulmonary amyloidosis | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hernia obstructive | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Hepatic enzyme abnormal | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Calciphylaxis | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Gastrointestinal procedural complication | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Failure to anastomose | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Iatrogenic injury | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Incarcerated incisional hernia | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Postoperative respiratory failure | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Procedural intestinal perforation | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Vulvovaginal injury | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Myasthenic syndrome | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Transient aphasia | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| VIth nerve paralysis | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Acute cardiac event | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Immune-mediated myocarditis | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pyelocaliectasis | Renal and urinary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Immune-mediated nephritis | Renal and urinary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Obstructive nephropathy | Renal and urinary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Urinary bladder polyp | Renal and urinary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Urogenital fistula | Renal and urinary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Vesical fistula | Renal and urinary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Acute monocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Acute myelomonocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Gallbladder adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Ovarian Sertoli-Leydig cell tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Polycythaemia vera | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V27.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Immune-mediated hypothyroidism | Endocrine disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Primary hypothyroidism | Endocrine disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Secondary adrenocortical insufficiency | Endocrine disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Degenerative bone disease | Musculoskeletal and connective tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Dermatitis exfoliative generalised | Skin and subcutaneous tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pelvic fluid collection | Reproductive system and breast disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pelvic haematoma | Reproductive system and breast disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA V27.0 | Systematic Assessment |
| |
| Ileostomy closure | Surgical and medical procedures | MedDRA V27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA V27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA V27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA V27.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA V27.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA V27.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 6, 2024 | Oct 29, 2025 | SAP_001.pdf |
Not provided
| 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 |
|---|---|
| C545685 | niraparib |
| C000719628 | dostarlimab |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| Adverse Event |
|
| Progression/clinical progression |
|
| Risk to Patient |
|
| Severe Noncompliance to Protocol |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Death |
|
| Other |
|
| Adverse Event |
|
| Thrombocytopenia Platelet Count not Returned to >=100000 cells/uL w/in |
|
| Progression/clinical progression |
|
| Risk to Patient |
|
| Severe Noncompliance to Protocol |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Death |
|
| Unblinded due to being randomized to Arm 1 |
|
| Investigator decision |
|
| Other |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Unknown |
|
| Not Reported |
|
|
|
| OG001 | Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3) | Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision |
|
|
|
|
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision |
|
|
| Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3) |
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision |
|
|
| Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3) |
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision |
|
|
| OG001 | Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3) | Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision |
|
|
| OG001 |
| Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3) |
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision |
|
|
|
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision |
| OG001 | Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3) | Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision |
|
|
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy.
Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
| OG001 | Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3) | Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision |
|
|
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision |
| OG001 | Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3) | Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision |
|
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|
| Stable |
|
| Improved |
|