Pembrolizumab/Placebo Plus Paclitaxel With or Without Bev... | NCT05116189

ID	Type	Description
MK-3475-B96	Other Identifier	MSD
KEYNOTE-B96	Other Identifier	MSD
ENGOT-ov65	Other Identifier	European Network of Gynaecological Oncological Trial groups
jRCT2051210184	Registry Identifier	Japan Registry of Clinical Trials (jRCT)
2023-506177-35-00	Registry Identifier	EU CT
U1111-1287-5318	Registry Identifier	UTN
2020-005027-37	EudraCT Number

Label	Type	Description	Intervention Names
Pembrolizumab + paclitaxel ± bevacizumab	Experimental	Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event (AE) requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.	Biological: Pembrolizumab Drug: Paclitaxel Drug: Bevacizumab Drug: Docetaxel
Placebo + paclitaxel ± bevacizumab	Placebo Comparator	Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event (AE) requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.	Drug: Paclitaxel Drug: Bevacizumab Other: Placebo for pembrolizumab Drug: Docetaxel

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab	Biological	IV infusion	Pembrolizumab + paclitaxel ± bevacizumab

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 Cell Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS] ≥1)	PFS was 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 was 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. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. Per protocol, PFS per RECIST 1.1 as assessed by the Investigator in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.	Up to ~38 months
PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants	PFS was 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 was 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. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. 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 ~38 months

Secondary Outcomes

Measure	Description	Time Frame
PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1	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. The appearance of one or more 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 (BICR) in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
Has received 1 or 2 prior lines of systemic therapy for ovarian cancer (OC), including at least 1 prior platinum-based therapy. Participants may have received a prior poly (ADP-ribose) polymerase inhibitor (PARPi), anti-programmed cell death 1 protein (PD-1)/anti-programmed cell death ligand 1 (PD-L1) therapy, bevacizumab, or hormonal therapy; these will not be considered a separate line of therapy. Any chemotherapy regimen change due to toxicity in the absence of disease progression will be considered part of the same line of therapy.
Has provided documented informed consent for the study.
Has radiographic evidence of disease progression within 6 months (180 days) after the last dose of platinum-based chemotherapy for OC (i.e., platinum-resistant disease).
Is a candidate for paclitaxel chemotherapy (and bevacizumab, if using).
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before randomization.
For a female participant, she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and uses a contraceptive method that is highly effective (with a failure rate of <1% per year).
Has radiographically evaluable disease, either measurable or nonmeasurable per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by the local site investigator.
Archival tumor tissue sample or newly obtained core or incisional/excisional biopsy of a tumor lesion not previously irradiated has been provided.
Have adequate organ function.

Exclusion Criteria:

Has nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma.
Has primary platinum-refractory disease, defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of first-line platinum-based therapy.
Has prior disease progression on weekly paclitaxel alone.
Has received >2 prior lines of systemic therapy for OC.
Has received prior systemic anticancer therapy including investigational agents or maintenance therapy (including bevacizumab maintenance therapy), within 4 weeks before randomization.
Has received prior radiation therapy within 2 weeks of start of study intervention.
Has not recovered adequately from surgery and/or any complications from the surgery.
Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor,[GM-CSF] or recombinant erythropoietin) within 4 weeks before randomization.
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Has received investigational agent or has used an investigational device within 4 weeks prior to study intervention.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has severe hypersensitivity (≥Grade 3) to pembrolizumab, paclitaxel, or bevacizumab (if using) and/or any of their excipients.
Has an active autoimmune disease that has required systemic treatment in the past 2 years.
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV) infection.
Has a known history of Hepatitis B or known active Hepatitis C virus infection.
Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study.
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
Participant, in the judgement of the investigator, is unlikely to comply with the study procedures, restrictions, and requirements of the study.
Has had an allogenic tissue/solid organ transplant.

For bevacizumab treatment

Has uncontrolled hypertension.
Has current, clinically relevant bowel obstruction including related to underlying epithelial OC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam.
Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before randomization.

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

Facility	Status	City	State	ZIP	Country	Contacts
HonorHealth ( Site 0041)		Phoenix	Arizona	85016	United States
Marin Cancer Care ( Site 0055)

PubMed Identifier	Type	Citation	Retractions
41974150	Derived	Colombo N, Zsiros E, Parma G, Rulli E, Sebastianelli A, Bidzinski M, Gallardo C, Matanes E, Hasegawa K, Kose F, Magallanes-Maciel M, Herbertson RA, Ananda S, Kroep JR, de Melo AC, Debruyne PR, Kim JW, Sehouli J, Pierre ME, Hietanen S, Zamagni C, Lu X, Monk BJ, Coleman RL, Peng X, Yamada K, Bogusz AM, De La Motte Rouge T, Wu X; ENGOT-ov65/KEYNOTE-B96 investigators. Pembrolizumab plus weekly paclitaxel in platinum-resistant recurrent ovarian cancer (ENGOT-ov65/KEYNOTE-B96): a multicentre, randomised, double-blind, phase 3 study. Lancet. 2026 Apr 18;407(10538):1525-1537. doi: 10.1016/S0140-6736(26)00602-1. Epub 2026 Apr 10.
37185961

Label	URL
Merck Clinical Trials Information	View source

ID	Title	Description
FG000	Pembrolizumab + Paclitaxel ± Bevacizumab	Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 31, 2024

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 Cell Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS] ≥1)

PFS was 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 was 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. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. Per protocol, PFS per RECIST 1.1 as assessed by the Investigator in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants with PD-L1 positive tumors (CPS≥1). Participants were analyzed in the treatment group to which they are randomized.

Posted

Median

95% Confidence Interval

Months

Up to ~38 months

ID	Title	Description
OG000	Pembrolizumab + Paclitaxel ± Bevacizumab	Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
OG001	Placebo + Paclitaxel ± Bevacizumab	Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.

Units	Counts
Participants	OG000234 OG001232

Title

Denominators

Categories

Title	Measurements
	OG0008.3(7.0 to 9.5) OG0017.2(6.2 to 8.1)

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 OG001	The hazard ratio (HR) and 95% confidence interval (CI) is based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by planned bevacizumab use in the study (yes vs no), region (US vs EU vs ROW) and PD-L1 status (CPS <1 vs CPS 1 to <10 vs CPS >=10). One-sided p-value based on log-rank test stratified by planned bevacizumab use in the study (yes vs no), region (US vs EU vs ROW) and PD-L1 status (CPS <1 vs CPS 1 to <10 vs CPS >=10).	Log Rank		0.0022	One-sided p-value based on log-rank test stratified by planned bevacizumab use in the study (yes vs no), region (US vs EU vs ROW) and PD-L1 status (CPS <1 vs CPS 1 to <10 vs CPS >=10).	Hazard Ratio (HR)	0.75			2-Sided	95	0.61	0.91

Primary

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

PFS was 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 was 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. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. 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 are randomized.

Posted

Median

95% Confidence Interval

Months

Up to ~38 months

ID	Title	Description
OG000	Pembrolizumab + Paclitaxel ± Bevacizumab	Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.

Secondary

PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1

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. The appearance of one or more 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 (BICR) in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants with PD-L1 positive tumors (CPS≥1). Participants were analyzed in the treatment group to which they are randomized.

Posted

Median

95% Confidence Interval

Months

Up to ~38 months

ID	Title	Description
OG000	Pembrolizumab + Paclitaxel ± Bevacizumab	Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.

Secondary

PFS Per RECIST 1.1 by Blinded Independent Central Review (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. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more 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 (BICR) in all participants is reported here. 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 are randomized.

Posted

Median

95% Confidence Interval

Months

Up to ~38 months

ID	Title	Description
OG000	Pembrolizumab + Paclitaxel ± Bevacizumab	Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.

Secondary

Overall Survival (OS)

OS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants.

Not Posted

Up to ~64 months

Participants

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 treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

Not Posted

Up to ~64 months

Participants

Secondary

Number of Participants Who Discontinue Study Treatment Due to an AE

Not Posted

Up to ~64 months

Participants

Secondary

Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.

Not Posted

Baseline and up to ~64 months

Participants

Secondary

Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30

TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Items 29 and 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.

Not Posted

Up to ~64 months

Participants

Secondary

Change From Baseline in the Abdominal and Gastrointestinal (GI) Symptoms Score (Items 31 to 36) Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale

The EORTC QLQ-OV28 is an abdominal and gastrointestinal questionnaire (items 31-36). Participant responses to the question "Did you have abdominal pain ?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-LC28 Items 31-36) score will be presented. A lower score indicates a better outcome.

Not Posted

Baseline and up to ~64 months

Participants

Secondary

TTD in the Abdominal and GI Symptoms Score (Items 31 to 36) Using the EORTC QLQ-OV28 Abdominal/GI Symptom Scale

TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C28 Items 31-36) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.

Not Posted

Up to ~64 months

Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0007 events7 affected320 at risk EG0016 events6 affected318 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0007 events7 affected320 at risk EG0012 events1 affected318 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0010 events0 affected318 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0012 events2 affected318 at risk
Myelosuppression	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0013 events2 affected318 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0012 events2 affected318 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Cardiac failure	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0011 events1 affected318 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Immune-mediated myocarditis	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0007 events7 affected320 at risk EG0010 events0 affected318 at risk
Hypophysitis	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0010 events0 affected318 at risk
Thyroiditis subacute	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0007 events7 affected320 at risk EG0013 events2 affected318 at risk
Anal ulcer	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Ascites	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0004 events3 affected320 at risk EG0017 events3 affected318 at risk
Colitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0005 events5 affected320 at risk EG0010 events0 affected318 at risk
Constipation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0013 events3 affected318 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0007 events7 affected320 at risk EG0011 events1 affected318 at risk
Duodenal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Enteritis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Gastritis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0012 events1 affected318 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Ileus	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0006 events4 affected320 at risk EG0010 events0 affected318 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0007 events6 affected320 at risk EG00112 events11 affected318 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected320 at risk EG0012 events2 affected318 at risk
Intestinal pseudo-obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Intra-abdominal fluid collection	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0013 events3 affected318 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0011 events1 affected318 at risk
Noninfective sialoadenitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Oesophageal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Proctitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Rectal perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0009 events7 affected320 at risk EG0014 events4 affected318 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Subileus	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Superior mesenteric artery syndrome	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0013 events3 affected318 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0007 events7 affected320 at risk EG0013 events3 affected318 at risk
Administration site extravasation	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Adverse drug reaction	General disorders	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected320 at risk EG0010 events0 affected318 at risk
Asthenia	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Catheter site erythema	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Chest pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0004 events3 affected320 at risk EG0010 events0 affected318 at risk
Death	General disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0011 events1 affected318 at risk
Fatigue	General disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected320 at risk EG0010 events0 affected318 at risk
General physical health deterioration	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Influenza like illness	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Malaise	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Oedema peripheral	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Peripheral swelling	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Pyrexia	General disorders	MedDRA 27.1	Systematic Assessment	EG00010 events8 affected320 at risk EG0013 events2 affected318 at risk
Sudden death	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Vascular device occlusion	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected320 at risk EG0011 events1 affected318 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0011 events1 affected318 at risk
Immune-mediated hepatic disorder	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Hypersensitivity	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Abdominal sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Abscess limb	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Anal abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0011 events1 affected318 at risk
Appendicitis perforated	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Bacteraemia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0012 events2 affected318 at risk
Bronchiolitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0007 events7 affected320 at risk EG0012 events2 affected318 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0010 events0 affected318 at risk
Catheter site infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Cellulitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0003 events2 affected320 at risk EG0012 events2 affected318 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Device related infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected320 at risk EG0012 events2 affected318 at risk
Diverticulitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Fournier's gangrene	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Gastroenteritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0010 events0 affected318 at risk
Herpes zoster	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Influenza	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0011 events1 affected318 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Peritoneal abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Peritonitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0012 events2 affected318 at risk
Pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00014 events14 affected320 at risk EG0014 events4 affected318 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0014 events3 affected318 at risk
Psoas abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0006 events6 affected320 at risk EG0013 events3 affected318 at risk
Septic shock	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0010 events0 affected318 at risk
Sinusitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Skin infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Soft tissue infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Tooth abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Tooth infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Tracheobronchitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0010 events0 affected318 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00017 events15 affected320 at risk EG0016 events6 affected318 at risk
Vulval cellulitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Vulvitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0010 events0 affected318 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Intestinal anastomosis complication	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Alanine aminotransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0011 events1 affected318 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Blood creatinine increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected320 at risk EG0012 events2 affected318 at risk
Blood phosphorus decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0010 events0 affected318 at risk
Liver function test increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Neutrophil count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0009 events7 affected320 at risk EG0018 events5 affected318 at risk
Platelet count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Transaminases increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
White blood cell count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0003 events2 affected320 at risk EG0012 events1 affected318 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0013 events3 affected318 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0008 events8 affected320 at risk EG0013 events2 affected318 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0010 events0 affected318 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected320 at risk EG0010 events0 affected318 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0010 events0 affected318 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0003 events1 affected320 at risk EG0010 events0 affected318 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0011 events1 affected318 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Immune-mediated arthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Immune-mediated myositis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Malignant neoplasm of ampulla of Vater	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Aphasia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Cerebral infarction	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Cerebrospinal fistula	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Embolic stroke	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Immune-mediated neuropathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Syncope	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0012 events2 affected318 at risk
Confusional state	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0013 events2 affected318 at risk
Bladder tamponade	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Haematuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Renal failure	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0010 events0 affected318 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Urinary retention	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Urinary tract disorder	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0011 events1 affected318 at risk
Acute interstitial pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0010 events0 affected318 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0010 events0 affected318 at risk
Malignant pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0011 events1 affected318 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected320 at risk EG0012 events2 affected318 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0011 events1 affected318 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0009 events9 affected320 at risk EG0017 events7 affected318 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Immune-mediated dermatitis	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Assisted suicide	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0010 events0 affected318 at risk
Arteriosclerosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0013 events3 affected318 at risk
Embolism	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Haematoma	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Hypertensive crisis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Hypertensive urgency	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Hypotension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
May-Thurner syndrome	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected320 at risk EG0010 events0 affected318 at risk
Shock	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected320 at risk EG0011 events1 affected318 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected320 at risk EG0010 events0 affected318 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG000365 events169 affected320 at risk EG001263 events148 affected318 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG00077 events24 affected320 at risk EG001100 events27 affected318 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG000186 events76 affected320 at risk EG001205 events81 affected318 at risk
Hypothyroidism	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG00067 events57 affected320 at risk EG00123 events19 affected318 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00030 events24 affected320 at risk EG00129 events26 affected318 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00095 events71 affected320 at risk EG001109 events82 affected318 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00022 events18 affected320 at risk EG00131 events20 affected318 at risk
Constipation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG000103 events76 affected320 at risk EG001102 events79 affected318 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG000285 events139 affected320 at risk EG001252 events126 affected318 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00026 events21 affected320 at risk EG00132 events28 affected318 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00032 events30 affected320 at risk EG00119 events16 affected318 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG000229 events130 affected320 at risk EG001170 events114 affected318 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00077 events56 affected320 at risk EG00140 events33 affected318 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG000145 events72 affected320 at risk EG001104 events73 affected318 at risk
Asthenia	General disorders	MedDRA 27.1	Systematic Assessment	EG00095 events60 affected320 at risk EG00191 events65 affected318 at risk
Fatigue	General disorders	MedDRA 27.1	Systematic Assessment	EG000163 events129 affected320 at risk EG001147 events119 affected318 at risk
Influenza like illness	General disorders	MedDRA 27.1	Systematic Assessment	EG00034 events27 affected320 at risk EG00118 events15 affected318 at risk
Malaise	General disorders	MedDRA 27.1	Systematic Assessment	EG00029 events25 affected320 at risk EG00152 events16 affected318 at risk
Mucosal inflammation	General disorders	MedDRA 27.1	Systematic Assessment	EG00045 events34 affected320 at risk EG00130 events27 affected318 at risk
Oedema peripheral	General disorders	MedDRA 27.1	Systematic Assessment	EG00065 events55 affected320 at risk EG00150 events43 affected318 at risk
Pyrexia	General disorders	MedDRA 27.1	Systematic Assessment	EG00095 events62 affected320 at risk EG00146 events37 affected318 at risk
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00047 events43 affected320 at risk EG00148 events47 affected318 at risk
Nasopharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00037 events28 affected320 at risk EG00127 events23 affected318 at risk
Paronychia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00033 events24 affected320 at risk EG00129 events28 affected318 at risk
Sinusitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00020 events18 affected320 at risk EG00111 events7 affected318 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00045 events32 affected320 at risk EG00141 events35 affected318 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG000172 events85 affected320 at risk EG001110 events69 affected318 at risk
Alanine aminotransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00068 events55 affected320 at risk EG00158 events33 affected318 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00075 events46 affected320 at risk EG00148 events32 affected318 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00030 events22 affected320 at risk EG00121 events18 affected318 at risk
Blood creatinine increased	Investigations	MedDRA 27.1	Systematic Assessment	EG00039 events26 affected320 at risk EG00123 events16 affected318 at risk
Lymphocyte count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG00062 events30 affected320 at risk EG00146 events18 affected318 at risk
Neutrophil count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG000520 events92 affected320 at risk EG001335 events71 affected318 at risk
Platelet count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG00035 events18 affected320 at risk EG00133 events10 affected318 at risk
Weight decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG00063 events38 affected320 at risk EG00115 events15 affected318 at risk
White blood cell count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG000467 events78 affected320 at risk EG001317 events59 affected318 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG000103 events75 affected320 at risk EG00170 events61 affected318 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00041 events21 affected320 at risk EG00149 events25 affected318 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00077 events43 affected320 at risk EG00124 events22 affected318 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00029 events21 affected320 at risk EG00122 events12 affected318 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00058 events34 affected320 at risk EG00148 events28 affected318 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00099 events53 affected320 at risk EG00180 events48 affected318 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00061 events43 affected320 at risk EG00146 events29 affected318 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00079 events55 affected320 at risk EG00166 events47 affected318 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00052 events46 affected320 at risk EG00152 events45 affected318 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00044 events39 affected320 at risk EG00149 events34 affected318 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00036 events29 affected320 at risk EG00139 events28 affected318 at risk
Dizziness	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00038 events33 affected320 at risk EG00131 events25 affected318 at risk
Dysgeusia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00039 events35 affected320 at risk EG00136 events33 affected318 at risk
Headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00050 events36 affected320 at risk EG00167 events54 affected318 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00029 events19 affected320 at risk EG00116 events13 affected318 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG000160 events126 affected320 at risk EG001133 events104 affected318 at risk
Paraesthesia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00023 events21 affected320 at risk EG00125 events21 affected318 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00050 events42 affected320 at risk EG00142 events37 affected318 at risk
Insomnia	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG00036 events34 affected320 at risk EG00137 events36 affected318 at risk
Proteinuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG00057 events40 affected320 at risk EG00145 events27 affected318 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG00081 events65 affected320 at risk EG00157 events49 affected318 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG00023 events23 affected320 at risk EG00115 events14 affected318 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG00061 events54 affected320 at risk EG00152 events46 affected318 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG000131 events102 affected320 at risk EG001102 events80 affected318 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG00020 events19 affected320 at risk EG00119 events17 affected318 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG00018 events17 affected320 at risk EG00120 events17 affected318 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG000124 events122 affected320 at risk EG001114 events112 affected318 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00023 events23 affected320 at risk EG00115 events11 affected318 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00018 events15 affected320 at risk EG00120 events18 affected318 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00025 events21 affected320 at risk EG00118 events16 affected318 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00055 events49 affected320 at risk EG00147 events42 affected318 at risk
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00045 events38 affected320 at risk EG00134 events32 affected318 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00042 events33 affected320 at risk EG00129 events28 affected318 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00087 events66 affected320 at risk EG00159 events42 affected318 at risk
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG00095 events64 affected320 at risk EG00198 events58 affected318 at risk

ID	Term
D010051	Ovarian Neoplasms
D000077216	Carcinoma, Ovarian Epithelial
D005185	Fallopian Tube 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
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D005184	Fallopian Tube Diseases

ID	Term
C582435	pembrolizumab
D017239	Paclitaxel
D000068258	Bevacizumab
D000077330	Saline Solution
D005947	Glucose
D000077143	Docetaxel

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
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
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates

ID	Title	Description
BG000	Pembrolizumab + Paclitaxel ± Bevacizumab	Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
BG001	Placebo + Paclitaxel ± Bevacizumab	Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
BG002	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	Pembrolizumab + Paclitaxel ± Bevacizumab	Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.	225	322	178	320	319	320
EG001	Placebo + Paclitaxel ± Bevacizumab	Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.	244	321	122	318	307	318