Study of Chemotherapy With Pembrolizumab (MK-3475) Follow... | NCT03740165

ID	Type	Description
ENGOT-ov43	Other Identifier	European Network of Gynaecological Oncological Trial Groups (ENGOT)
MK-7339-001	Other Identifier	MSD
KEYLYNK-001	Other Identifier	MSD
194619	Registry Identifier	Japic-CTI
GOG-3036	Other Identifier	Gynecologic Oncology Group (GOG)
2022-502124-52-00	Registry Identifier	EU CT
U1111-1283-3793	Registry Identifier	UTN
2018-001973-25	EudraCT Number

Name	Class
European Network of Gynaecological Oncological Trial Groups (ENGOT)	OTHER
Gynecologic Oncology Group	NETWORK

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Experimental	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.	Biological: Pembrolizumab Drug: Carboplatin Drug: Paclitaxel Drug: Olaparib Biological: Bevacizumab Drug: Docetaxel
Carboplatin + Paclitaxel + Pembrolizumab	Experimental	Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles starting in Cycle 1 PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.	Biological: Pembrolizumab Drug: Carboplatin Drug: Paclitaxel Drug: Placebo for olaparib Biological: Bevacizumab Drug: Docetaxel
Carboplatin + Paclitaxel	Active Comparator	Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles PLUS placebo for pembrolizumab (normal saline or dextrose) via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab	Biological	IV infusion	Carboplatin + Paclitaxel + Pembrolizumab Carboplatin + Paclitaxel + Pembrolizumab + Olaparib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS]≥10)	PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for participants with PD-L1 positive tumors (CPS≥10). PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.	Up to approximately 67 months
PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants	PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for all participants. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.	Up to approximately 67 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS) in Participants With PD-L1 Positive Tumors (CPS ≥ 10)	OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all participants with PD-L1 positive tumors (CPS≥10). The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.	Up to approximately 67 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer
Has just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery
Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting
Candidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25
Is able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1
Female participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Has adequate organ function

Exclusion Criteria:

Has mucinous, germ cell, or borderline tumor of the ovary
Has a known or suspected deleterious mutation (germline or somatic) in either BRCA1 or BRCA2
Has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis
Has either myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
Has a known additional malignancy that is progressing or has required active treatment in the last 3 years Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. ductal carcinoma in situ, cervical carcinoma in situ) that has undergone potentially curative therapy are not excluded.
Has ongoing Grade 3 or Grade 4 toxicity, excluding alopecia, following chemotherapy administered during the lead-in period
Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with brain metastases may participate provided they were previously treated (except with chemotherapy) and are radiologically stable, clinically stable, and no steroids were used for the management of symptoms related to brain metastases within 14 days prior to randomization. Stable brain metastases should be established prior to the first dose of study medication lead-in chemotherapy
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
Has a known history of active tuberculosis (TB; Bacillus Tuberculosis)
Has an active infection requiring systemic therapy
Has received colony-stimulating factors (eg, granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 4 weeks prior to receiving chemotherapy during the lead-in period
Is considered to be of poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection
Has had surgery to treat borderline tumors, early stage EOC, or early stage fallopian tube cancer <6 months prior to screening
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Testing for hepatitis B or hepatitis C is required at screening only if mandated by local health authority. Note: Participants with a history of hepatitis B but who are HBsAg negative are eligible for the study
Is either unable to swallow orally administered medication or has a gastrointestinal (GI) disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, malabsorption)
Has uncontrolled hypertension
Has current, clinically relevant bowel obstruction (including sub-occlusive disease), abdominal fistula or GI perforation, related to underlying EOC (for participants receiving bevacizumab)
Has a history of hemorrhage, hemoptysis or active GI bleeding within 6 months prior to randomization (for participants receiving bevacizumab)
Is a WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of chemotherapy in the lead-in period and within 72 hours prior to Day 1 of Cycle 1, is pregnant or breastfeeding, or is expecting to conceive children within the projected duration of the study, starting with screening through 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy
Has received prior treatment for any stage of OC, including radiation or systemic anti-cancer therapy (e.g. chemotherapy, hormonal therapy, immunotherapy, investigational therapy)
Has received prior therapy with an anti-Programmed Cell Death-1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T lymphocyte antigen-4 [CTLA-4], OX 40, CD137)
Has received prior therapy with either olaparib or any other poly(adenosine-ribose) polymerase (PARP) inhibitor
Has intraperitoneal chemotherapy planned or has been administered as first-line therapy
Has received a live vaccine within 30 days prior to the first dose of study treatment on Day 1 of Cycle 1
Has severe hypersensitivity (≥Grade 3) to pembrolizumab, olaparib, carboplatin, paclitaxel or bevacizumab (if using) and/or any of their excipients
Is currently receiving either strong (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
Is currently receiving either strong (e.g. phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine, and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study
Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks (28 days) of starting chemotherapy in the Lead-in Period
Has resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions or participant has congenital long QT syndrome
Has had an allogenic tissue/solid organ transplant, has received previous allogenic bone-marrow transplant, or has received double umbilical cord transplantation
Either has had major surgery within 3 weeks of randomization or has not recovered from any effects of any major surgery

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham (UAB) ( Site 0036)		Birmingham	Alabama	35233	United States
University of Arizona Cancer Center ( Site 0074)

Label	URL
Merck Clinical Trials Information	View source
Plain Language Summary	View source

ID	Title	Description
FG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 19, 2025	Oct 3, 2025

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) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS]≥10)

PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for participants with PD-L1 positive tumors (CPS≥10). PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 67 months

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
OG001	Carboplatin + Paclitaxel + Pembrolizumab	Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles starting in Cycle 1 PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
OG002	Carboplatin + Paclitaxel	Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles PLUS placebo for pembrolizumab (normal saline or dextrose) via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Units	Counts
Participants	OG000229 OG001230 OG002228

Title

Denominators

Categories

Title	Measurements
	OG00023.9(21.0 to 30.2) OG00117.3(15.2 to 19.4) OG00215.2(12.5 to 17.2)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Log Rank		0.0002	One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)	Hazard Ratio (HR)	0.66			2-Sided	95	0.53	0.83			Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)		Superiority

Primary

PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants

PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for all participants. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 67 months

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Secondary

Overall Survival (OS) in Participants With PD-L1 Positive Tumors (CPS ≥ 10)

OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all participants with PD-L1 positive tumors (CPS≥10). The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 67 months

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
OG001	Carboplatin + Paclitaxel + Pembrolizumab	Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles starting in Cycle 1 PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Secondary

OS in All Participants

OS is defined as the time from the date of randomization to death due to any cause. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 67 months

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
OG001	Carboplatin + Paclitaxel + Pembrolizumab	Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles starting in Cycle 1 PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Secondary

PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR) in Participants With PD-L1 Positive Tumors (CPS≥10)

PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review will be reported for participants with PD-L1 positive (CPS≥10) tumors (CPS≥10). PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 66 months

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Secondary

PFS Per RECIST 1.1 as Assessed by BICR in All Participants

PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review will be reported for all participants. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 66 months

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Secondary

PFS After Second-line Treatment (PFS2) Following Discontinuation of Study Treatment as Assessed by the Investigator in Participants With PD-L1 Positive Tumors (CPS≥10)

PFS2 is defined as the time from randomization until PD after second-line treatment per RECIST 1.1 based on Investigator assessment, or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS2 per RECIST 1.1 as assessed by the Investigator is reported for participants with PD-L1 positive tumors (CPS≥10). PFS2 was calculated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 67 months

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Secondary

PFS2 Following Discontinuation of Study Treatment as Assessed by the Investigator in All Participants

PFS2 is defined as the time from randomization until PD after second-line treatment per RECIST 1.1 based on Investigator assessment, or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS2 per RECIST 1.1 as assessed by the Investigator is reported for all participants. PFS2 was calculated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 67 months

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Secondary

Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) (GHS/QoL) Combined Score

The EORTC-QLQ-C30 is a 30-item questionnaire to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor; 7=Excellent). Using linear transformation, raw scores were standardized so scores ranged from 0 to 100; higher score = better outcome. Change from baseline to Week 45 in EORTC QLQ-C30 Items 29 and 30 combined scores was calculated based on a constrained longitudinal data analysis (cLDA) with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery [planned interval vs R0 following primary vs R1 following primary], and bevacizumab use [Yes vs No], and PD-L1 CPS [<10 vs ≥10]).

The analysis population includes all randomized participants who have at least 1 GHS/QoL assessment available and received at least 1 dose of study medication. Participants were analyzed in the treatment group to which they were randomized.

Posted

Least Squares Mean

95% Confidence Interval

Score on a Scale

Baseline and week 45

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Secondary

Mean Change From Baseline in Abdominal and Gastrointestinal (Abdominal/GI) Symptoms Score Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale

Participant responses to 6 questions from the EORTC QoL Questionnaire-Ovarian Cancer (QLQ-OV28) abdominal/GI symptom scale about abdominal pain, bloated feeling in abdomen/stomach, changes in clothing fit, changes in bowel habit, flatulence, and stomach fullness when eating (questions 31-36) were scored on a 4-point scale (1=Not at all; 4=Very much); lower score = better abdominal/GI symptoms. Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100; a lower score indicating a better overall outcome. Change from baseline to Week 45 in EORTC QLQ-OV28 Items 31-36 combined scores was calculated based on a constrained longitudinal data analysis (cLDA) model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery [planned interval vs R0 following primary vs R1 following primary], and bevacizumab use [Yes vs No], and PD-L1 CPS [<10 vs ≥10]).

The analysis population includes all randomized participants who have at least 1 Abdominal/GI Symptom Scale assessment available and received at least 1 dose of study medication. Participants were analyzed in the treatment group to which they were randomized.

Posted

Least Squares Mean

95% Confidence Interval

Score on a Scale

Baseline and week 45

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Secondary

Time to Deterioration (TTD) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

The EORTC-QLQ-C30 is a 30-item questionnaire to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor; 7=Excellent). Using linear transformation, raw scores were standardized so scores ranged from 0 to 100; higher score = better outcome. TTD is defined as the time from the first EORTC QLQ-C30 Items 29 and 30 combined scores to deterioration (defined as ≥10-point decrease in GHS/QoL score from baseline with confirmation under right-censoring rule [the last observation]) or death, whichever occurs first. TTD was calculated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants who have at least 1 GHS/QoL assessment available plus a baseline assessment, and received at least 1 dose of study medication. Participants were analyzed in the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 31 months

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Secondary

Time to Deterioration (TTD) of Abdominal/GI Symptoms Using EORTC QLQ-OV28

Participant responses to 6 questions from the EORTC QoL Questionnaire-Ovarian Cancer (QLQ-OV28) abdominal/GI symptom scale about abdominal pain, bloated feeling in abdomen/stomach, changes in clothing fit, changes in bowel habit, flatulence, and stomach fullness when eating (questions 31-36) were scored on a 4-point scale (1=Not at all; 4=Very much); lower score = better abdominal/GI symptoms. Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100; a lower score indicating a better overall outcome. TTD is defined as the time from the first EORTC QLQ-OV28 questions 31-36 combined scores to deterioration (defined as ≥10-point decrease in abdominal/GI symptoms score from baseline with confirmation under right-censoring rule [the last observation]) or death, whichever occurs first. TTD was calculated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants who have at least 1 Abdominal/GI Symptom Scale assessment available plus a baseline assessment, and received at least 1 dose of study medication. Participants were analyzed in the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 31 months

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Secondary

Time to First Subsequent Anti-cancer Treatment (TFST) in Participants With PD-L1 Positive Tumors (CPS≥10)

TFST is defined as the time from randomization to initiation of first subsequent anti-cancer treatment or death due to any cause, whichever occurs first. The TFST was determined from the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 67 months

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
OG001	Carboplatin + Paclitaxel + Pembrolizumab	Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles starting in Cycle 1 PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Secondary

Time to First Subsequent Anti-cancer Treatment (TFST) in All Participants

The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 67 months

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
OG001	Carboplatin + Paclitaxel + Pembrolizumab	Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles starting in Cycle 1 PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Secondary

Time to Second Subsequent Anti-cancer Treatment (TSST) in Participants With PD-L1 Positive Tumors (CPS≥10)

TSST is defined as the time from randomization to initiation of second subsequent anti-cancer treatment or death due to any cause, whichever occurs first. The TSST was determined from the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 67 months

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
OG001	Carboplatin + Paclitaxel + Pembrolizumab	Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles starting in Cycle 1 PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Secondary

Time to Second Subsequent Anti-cancer Treatment (TSST) in All Participants

The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 67 months

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
OG001	Carboplatin + Paclitaxel + Pembrolizumab	Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles starting in Cycle 1 PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Secondary

Time to Discontinuation of Study Treatment or Death (TDT) in Participants With PD-L1 Positive Tumors (CPS≥10)

TDT is defined as the time from the date of randomization to discontinuation of study treatment or death due to any cause, whichever occurs first. The TDT was determined from the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 67 months

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
OG001	Carboplatin + Paclitaxel + Pembrolizumab	Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles starting in Cycle 1 PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Secondary

Time to Discontinuation of Study Treatment or Death (TDT) in All Participants

The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Up to approximately 67 months

ID	Title	Description
OG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
OG001	Carboplatin + Paclitaxel + Pembrolizumab	Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles starting in Cycle 1 PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Secondary

Pathological Complete Response (pCR) Rate in Participants With PD-L1 Positive Tumors (CPS≥10)

pCR is defined as the disappearance of all known disease noted prior to surgery; all surgical specimens collected during the interval debulking surgery are microscopically negative for malignancy. The percentage of participants who experience pCR was determined based on Miettinen & Nurminen method stratified by Bevacizumab use (yes versus no).

The analysis population includes all randomized participants with CPS≥10 who had pCR evaluation. Participants were analyzed in the treatment group to which they were randomized.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 21 months

ID	Title	Description
OG000	Pooled Carboplatin+Paclitaxel+Pembrolizumab+Olaparib, and Carboplatin+Paclitaxel+Pembrolizumab	This arm represents all participants who received pembrolizumab, per the pre-specified statistical analysis plan. Participants received carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS EITHER olaparib 300 mg OR placebo for olaparib via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
OG001

Secondary

Pathological Complete Response (pCR) Rate in All Participants

The analysis population includes all randomized participants who had pCR evaluation. Participants were analyzed in the treatment group to which they were randomized.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 26 months

ID	Title	Description
OG000	Pooled Carboplatin+Paclitaxel+Pembrolizumab+Olaparib, and Carboplatin+Paclitaxel+Pembrolizumab	This arm represents all participants who received pembrolizumab, per the pre-specified statistical analysis plan. Participants received carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS EITHER olaparib 300 mg OR placebo for olaparib via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
OG001

Secondary

Number of Participants Who Experience an Adverse Event (AE)

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

Not Posted

May 2027

Up to approximately 73 months (anticipated)

Participants

Secondary

Number of Participants Who Discontinue Study Treatment Due to an AE

Not Posted

May 2027

Up to approximately 6 years (anticipated)

Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0006 events6 affected452 at risk EG0015 events5 affected456 at risk EG0024 events4 affected454 at risk
Aplasia pure red cell	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG00019 events19 affected452 at risk EG00117 events16 affected456 at risk EG00211 events9 affected454 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0005 events5 affected452 at risk EG0013 events3 affected456 at risk EG0023 events3 affected454 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected452 at risk EG0011 events1 affected456 at risk EG0022 events2 affected454 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Angina pectoris	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Angina unstable	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0013 events3 affected456 at risk EG0020 events0 affected454 at risk
Autoimmune myocarditis	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Bundle branch block left	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Coronary artery disease	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Myocardial infarction	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0012 events2 affected456 at risk EG0022 events2 affected454 at risk
Myocarditis	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Ventricular hypokinesia	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected452 at risk EG0014 events4 affected456 at risk EG0020 events0 affected454 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Hypophysitis	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0012 events2 affected456 at risk EG0020 events0 affected454 at risk
Hypopituitarism	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0012 events2 affected456 at risk EG0020 events0 affected454 at risk
Hypothyroidism	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Thyroid disorder	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Thyroiditis	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Macular hole	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Vogt-Koyanagi-Harada disease	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0022 events2 affected454 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected452 at risk EG0011 events1 affected456 at risk EG0022 events2 affected454 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Ascites	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0014 events4 affected456 at risk EG0022 events2 affected454 at risk
Colitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected452 at risk EG0017 events6 affected456 at risk EG0022 events2 affected454 at risk
Colonic fistula	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Constipation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0013 events3 affected456 at risk EG0020 events0 affected454 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0006 events4 affected452 at risk EG0013 events2 affected456 at risk EG0021 events1 affected454 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Enteritis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0010 events0 affected456 at risk EG0022 events2 affected454 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0012 events2 affected456 at risk EG0020 events0 affected454 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0015 events5 affected456 at risk EG0020 events0 affected454 at risk
Flatulence	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0021 events1 affected454 at risk
Gastritis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0021 events1 affected454 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Hernial eventration	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Ileal perforation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Ileus	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0006 events6 affected452 at risk EG0018 events6 affected456 at risk EG0024 events4 affected454 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0012 events2 affected456 at risk EG0020 events0 affected454 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00011 events8 affected452 at risk EG00110 events9 affected456 at risk EG0026 events6 affected454 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0022 events2 affected454 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0011 events1 affected456 at risk EG0021 events1 affected454 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Melaena	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0004 events2 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Pancreatic fistula	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0022 events2 affected454 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0008 events7 affected452 at risk EG0018 events7 affected456 at risk EG00211 events7 affected454 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Subileus	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0021 events1 affected454 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0005 events4 affected452 at risk EG0013 events3 affected456 at risk EG0021 events1 affected454 at risk
Administration site extravasation	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Asthenia	General disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0011 events1 affected456 at risk EG0022 events2 affected454 at risk
Chest pain	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Death	General disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0011 events1 affected456 at risk EG0021 events1 affected454 at risk
Fatigue	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0022 events2 affected454 at risk
General physical health deterioration	General disorders	MedDRA 27.0	Systematic Assessment	EG0003 events2 affected452 at risk EG0011 events1 affected456 at risk EG0022 events2 affected454 at risk
Hernia	General disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0011 events1 affected456 at risk EG0021 events1 affected454 at risk
Hyperpyrexia	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Ill-defined disorder	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Influenza like illness	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Infusion site extravasation	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Malaise	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0022 events1 affected454 at risk
Mucosal inflammation	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Non-cardiac chest pain	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Performance status decreased	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Pyrexia	General disorders	MedDRA 27.0	Systematic Assessment	EG00018 events15 affected452 at risk EG0019 events7 affected456 at risk EG0024 events4 affected454 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Vaccination site reaction	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0012 events2 affected456 at risk EG0020 events0 affected454 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Biliary fistula	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Cholangitis sclerosing	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0011 events1 affected456 at risk EG0021 events1 affected454 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0011 events1 affected456 at risk EG0022 events2 affected454 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0021 events1 affected454 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Hepatic cytolysis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Hepatic haemorrhage	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Hepatic necrosis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Hepatobiliary disease	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0022 events1 affected454 at risk
Liver injury	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0012 events2 affected456 at risk EG0020 events0 affected454 at risk
Contrast media allergy	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0013 events1 affected456 at risk EG0020 events0 affected454 at risk
Eosinophilic granulomatosis with polyangiitis	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Haemophagocytic lymphohistiocytosis	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Hypersensitivity	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0012 events2 affected456 at risk EG0021 events1 affected454 at risk
Type IV hypersensitivity reaction	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Abdominal abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0022 events2 affected454 at risk
Abdominal infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0014 events3 affected456 at risk EG0020 events0 affected454 at risk
Acid fast bacilli infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Anal abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Bacteraemia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Biloma infected	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0012 events1 affected456 at risk EG0020 events0 affected454 at risk
Bronchitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
COVID-19	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0009 events9 affected452 at risk EG0012 events2 affected456 at risk EG0024 events3 affected454 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0006 events6 affected452 at risk EG0014 events4 affected456 at risk EG0022 events2 affected454 at risk
Cellulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0022 events2 affected454 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Colostomy infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Device related infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected452 at risk EG0014 events3 affected456 at risk EG0021 events1 affected454 at risk
Device related sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0011 events1 affected456 at risk EG0021 events1 affected454 at risk
Diverticulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0010 events0 affected456 at risk EG0022 events2 affected454 at risk
Encephalitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0012 events2 affected456 at risk EG0020 events0 affected454 at risk
Enterocolitis bacterial	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Erysipelas	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0022 events1 affected454 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Gastroenteritis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Hepatitis E	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Herpes zoster	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0012 events2 affected456 at risk EG0020 events0 affected454 at risk
Infected cyst	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Infected lymphocele	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Infected seroma	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Kidney infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Klebsiella infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Malaria	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Mastitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Pelvic abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0011 events1 affected456 at risk EG0021 events1 affected454 at risk
Periodontitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Perirectal abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Peritonitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0012 events2 affected456 at risk EG0020 events0 affected454 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0009 events7 affected452 at risk EG0018 events8 affected456 at risk EG0021 events1 affected454 at risk
Pneumonia aspiration	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Pneumonia viral	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Post procedural infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Postoperative wound infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0022 events2 affected454 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Pyelonephritis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0003 events2 affected452 at risk EG0012 events2 affected456 at risk EG0020 events0 affected454 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0012 events2 affected456 at risk EG0021 events1 affected454 at risk
Rhinovirus infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected452 at risk EG0013 events3 affected456 at risk EG0025 events5 affected454 at risk
Septic shock	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0012 events2 affected456 at risk EG0021 events1 affected454 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Tonsillitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00017 events14 affected452 at risk EG0017 events7 affected456 at risk EG00210 events9 affected454 at risk
Urosepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Vaginal infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Viral infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Viral pharyngitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Wound infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Anastomotic complication	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Anastomotic stenosis	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Chemical peritonitis	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0012 events1 affected456 at risk EG0020 events0 affected454 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Gastrointestinal stoma necrosis	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected452 at risk EG0010 events0 affected456 at risk EG0022 events2 affected454 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Post procedural fistula	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0021 events1 affected454 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0022 events2 affected454 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0012 events2 affected456 at risk EG0021 events1 affected454 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Stoma complication	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Wound evisceration	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Alanine aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0013 events3 affected456 at risk EG0021 events1 affected454 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0012 events1 affected456 at risk EG0020 events0 affected454 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Blood bilirubin increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Coagulation factor decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Hepatic enzyme increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Liver function test increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Neutrophil count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0011 events1 affected456 at risk EG0021 events1 affected454 at risk
Platelet count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0014 events4 affected456 at risk EG0020 events0 affected454 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0012 events2 affected456 at risk EG0020 events0 affected454 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected452 at risk EG0014 events4 affected456 at risk EG0020 events0 affected454 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0011 events1 affected456 at risk EG0021 events1 affected454 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Endocrine neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Endometrial stromal sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Intraductal papilloma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Uterine carcinoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Brain oedema	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Cerebral infarction	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Dizziness	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Encephalopathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Hemiparesis	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
IIIrd nerve paralysis	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0012 events2 affected456 at risk EG0021 events1 affected454 at risk
Meningitis noninfective	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Motor neurone disease	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Partial seizures	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Polyneuropathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Presyncope	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0013 events2 affected456 at risk EG0020 events0 affected454 at risk
Sciatica	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Somnolence	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Syncope	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0012 events2 affected456 at risk EG0020 events0 affected454 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Device occlusion	Product Issues	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Confusional state	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Delirium	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0013 events3 affected456 at risk EG0020 events0 affected454 at risk
Depression	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Mental status changes	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Suicide attempt	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0012 events2 affected456 at risk EG0020 events0 affected454 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0007 events5 affected452 at risk EG0013 events3 affected456 at risk EG0021 events1 affected454 at risk
Bladder perforation	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0022 events2 affected454 at risk
Nephritis	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Renal colic	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Renal failure	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Renal impairment	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0012 events2 affected456 at risk EG0020 events0 affected454 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Urinary retention	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0013 events1 affected456 at risk EG0021 events1 affected454 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0013 events3 affected456 at risk EG0024 events3 affected454 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0006 events5 affected452 at risk EG0014 events4 affected456 at risk EG0021 events1 affected454 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0006 events6 affected452 at risk EG0014 events4 affected456 at risk EG0021 events1 affected454 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Immune-mediated dermatitis	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0013 events3 affected456 at risk EG0020 events0 affected454 at risk
Euthanasia	Surgical and medical procedures	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Arterial thrombosis	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Embolism	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0012 events2 affected456 at risk EG0020 events0 affected454 at risk
Haematoma	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Hypertension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Hypertensive crisis	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0012 events2 affected456 at risk EG0020 events0 affected454 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Lymphocele	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk
Lymphoedema	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0010 events0 affected456 at risk EG0021 events1 affected454 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected452 at risk EG0010 events0 affected456 at risk EG0020 events0 affected454 at risk
Vasculitis	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected452 at risk EG0011 events1 affected456 at risk EG0020 events0 affected454 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG000488 events270 affected452 at risk EG001344 events212 affected456 at risk EG002322 events205 affected454 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG000201 events90 affected452 at risk EG001110 events60 affected456 at risk EG002113 events60 affected454 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG000437 events170 affected452 at risk EG001309 events138 affected456 at risk EG002317 events147 affected454 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG000180 events89 affected452 at risk EG001127 events73 affected456 at risk EG002127 events72 affected454 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG00037 events33 affected452 at risk EG00149 events44 affected456 at risk EG00225 events23 affected454 at risk
Hypothyroidism	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG000107 events89 affected452 at risk EG001111 events93 affected456 at risk EG00250 events42 affected454 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00028 events26 affected452 at risk EG00128 events26 affected456 at risk EG00229 events24 affected454 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG000133 events91 affected452 at risk EG001114 events90 affected456 at risk EG002143 events102 affected454 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00070 events50 affected452 at risk EG00167 events54 affected456 at risk EG00249 events42 affected454 at risk
Constipation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG000166 events121 affected452 at risk EG001147 events122 affected456 at risk EG002137 events104 affected454 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG000194 events121 affected452 at risk EG001247 events138 affected456 at risk EG002149 events94 affected454 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00044 events40 affected452 at risk EG00125 events22 affected456 at risk EG00231 events28 affected454 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG000432 events227 affected452 at risk EG001321 events187 affected456 at risk EG002262 events150 affected454 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00052 events46 affected452 at risk EG00141 events35 affected456 at risk EG00245 events30 affected454 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG000172 events114 affected452 at risk EG001120 events81 affected456 at risk EG00294 events70 affected454 at risk
Asthenia	General disorders	MedDRA 27.0	Systematic Assessment	EG000176 events116 affected452 at risk EG001158 events97 affected456 at risk EG002108 events70 affected454 at risk
Fatigue	General disorders	MedDRA 27.0	Systematic Assessment	EG000159 events120 affected452 at risk EG001179 events115 affected456 at risk EG002118 events85 affected454 at risk
Mucosal inflammation	General disorders	MedDRA 27.0	Systematic Assessment	EG00041 events33 affected452 at risk EG00130 events23 affected456 at risk EG00223 events17 affected454 at risk
Oedema peripheral	General disorders	MedDRA 27.0	Systematic Assessment	EG00039 events35 affected452 at risk EG00133 events28 affected456 at risk EG00250 events36 affected454 at risk
Pyrexia	General disorders	MedDRA 27.0	Systematic Assessment	EG00085 events66 affected452 at risk EG00165 events50 affected456 at risk EG00242 events34 affected454 at risk
COVID-19	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00070 events65 affected452 at risk EG00157 events53 affected456 at risk EG00253 events53 affected454 at risk
Cystitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00041 events24 affected452 at risk EG00120 events15 affected456 at risk EG00219 events14 affected454 at risk
Nasopharyngitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00027 events21 affected452 at risk EG00134 events26 affected456 at risk EG00248 events30 affected454 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG000151 events91 affected452 at risk EG001130 events79 affected456 at risk EG002144 events85 affected454 at risk
Alanine aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG000114 events74 affected452 at risk EG001102 events65 affected456 at risk EG002115 events71 affected454 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG000110 events68 affected452 at risk EG001112 events64 affected456 at risk EG002109 events59 affected454 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG00035 events26 affected452 at risk EG00155 events33 affected456 at risk EG00238 events22 affected454 at risk
Blood creatinine increased	Investigations	MedDRA 27.0	Systematic Assessment	EG00092 events46 affected452 at risk EG00127 events21 affected456 at risk EG00230 events22 affected454 at risk
Lymphocyte count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG00061 events28 affected452 at risk EG00149 events19 affected456 at risk EG00221 events7 affected454 at risk
Neutrophil count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG000336 events104 affected452 at risk EG001236 events96 affected456 at risk EG002244 events102 affected454 at risk
Platelet count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG000133 events79 affected452 at risk EG001117 events65 affected456 at risk EG002107 events58 affected454 at risk
Weight decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG00054 events51 affected452 at risk EG00138 events37 affected456 at risk EG00228 events28 affected454 at risk
Weight increased	Investigations	MedDRA 27.0	Systematic Assessment	EG00014 events12 affected452 at risk EG00124 events23 affected456 at risk EG00220 events18 affected454 at risk
White blood cell count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG000254 events88 affected452 at risk EG001154 events63 affected456 at risk EG002187 events80 affected454 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG000105 events83 affected452 at risk EG00188 events69 affected456 at risk EG00263 events52 affected454 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG00038 events23 affected452 at risk EG00121 events18 affected456 at risk EG00230 events20 affected454 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG00078 events43 affected452 at risk EG00155 events44 affected456 at risk EG00234 events21 affected454 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG00081 events49 affected452 at risk EG00181 events53 affected456 at risk EG00298 events58 affected454 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG00039 events24 affected452 at risk EG00135 events23 affected456 at risk EG00230 events20 affected454 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG000211 events136 affected452 at risk EG001243 events142 affected456 at risk EG002229 events139 affected454 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG00077 events63 affected452 at risk EG00155 events48 affected456 at risk EG00276 events67 affected454 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG00033 events20 affected452 at risk EG00116 events13 affected456 at risk EG00233 events23 affected454 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG000104 events72 affected452 at risk EG001124 events82 affected456 at risk EG00298 events75 affected454 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG00058 events38 affected452 at risk EG00179 events61 affected456 at risk EG00265 events45 affected454 at risk
Dizziness	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00063 events52 affected452 at risk EG00157 events41 affected456 at risk EG00258 events43 affected454 at risk
Dysgeusia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00051 events41 affected452 at risk EG00136 events35 affected456 at risk EG00230 events22 affected454 at risk
Headache	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG000119 events87 affected452 at risk EG001103 events67 affected456 at risk EG002115 events77 affected454 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00035 events23 affected452 at risk EG00131 events18 affected456 at risk EG00231 events22 affected454 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00093 events85 affected452 at risk EG001101 events91 affected456 at risk EG00296 events83 affected454 at risk
Paraesthesia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00038 events32 affected452 at risk EG00133 events32 affected456 at risk EG00244 events35 affected454 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00071 events54 affected452 at risk EG00177 events68 affected456 at risk EG00265 events56 affected454 at risk
Anxiety	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG00020 events19 affected452 at risk EG00122 events21 affected456 at risk EG00224 events23 affected454 at risk
Insomnia	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG00045 events35 affected452 at risk EG00145 events38 affected456 at risk EG00251 events45 affected454 at risk
Dysuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG00031 events29 affected452 at risk EG00111 events11 affected456 at risk EG00224 events17 affected454 at risk
Proteinuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG00056 events33 affected452 at risk EG00150 events36 affected456 at risk EG00244 events37 affected454 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG00049 events46 affected452 at risk EG00154 events46 affected456 at risk EG00254 events41 affected454 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG00065 events55 affected452 at risk EG00161 events51 affected456 at risk EG00250 events41 affected454 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG00047 events38 affected452 at risk EG00154 events38 affected456 at risk EG00267 events47 affected454 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG00032 events30 affected452 at risk EG00120 events17 affected456 at risk EG00230 events26 affected454 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG000125 events123 affected452 at risk EG001115 events114 affected456 at risk EG002131 events131 affected454 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG00082 events63 affected452 at risk EG00195 events69 affected456 at risk EG00274 events57 affected454 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG00088 events69 affected452 at risk EG00192 events71 affected456 at risk EG00251 events42 affected454 at risk
Hot flush	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG00023 events18 affected452 at risk EG00125 events23 affected456 at risk EG00233 events29 affected454 at risk
Hypertension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG00060 events52 affected452 at risk EG00199 events76 affected456 at risk EG002103 events76 affected454 at risk

ID	Term
D010051	Ovarian Neoplasms
D005185	Fallopian Tube Neoplasms
D010534	Peritoneal Neoplasms
C565324	Parkinson Disease 4, Autosomal Dominant Lewy Body

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders
D005184	Fallopian Tube Diseases
D000008	Abdominal Neoplasms
D004067	Digestive System Neoplasms
D004066	Digestive System Diseases
D010532	Peritoneal Diseases

ID	Term
C582435	pembrolizumab
D000077330	Saline Solution
D005947	Glucose
D016190	Carboplatin
D017239	Paclitaxel
C531550	olaparib
D000068258	Bevacizumab
D000077143	Docetaxel

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates
D056831	Coordination Complexes
D009930	Organic Chemicals
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D004224	Diterpenes
D013729	Terpenes
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
BG001	Carboplatin + Paclitaxel + Pembrolizumab	Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles starting in Cycle 1 PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
BG002	Carboplatin + Paclitaxel	Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles PLUS placebo for pembrolizumab (normal saline or dextrose) via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Carboplatin + Paclitaxel + Pembrolizumab + Olaparib	Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.	237	455	205	452	445	452
EG001	Carboplatin + Paclitaxel + Pembrolizumab	Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles starting in Cycle 1 PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.	243	458	179	456	442	456
EG002	Carboplatin + Paclitaxel	Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles PLUS placebo for pembrolizumab (normal saline or dextrose) via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.	229	454	122	454	445	454