Durvalumab With or Without Olaparib as Maintenance Therap... | NCT04269200

ID	Type	Description
GOG-3041	Other Identifier	Gynecologic Oncology Group(GOG) Foundation Inc
ENGOT-EN10	Other Identifier	The European Network for Gynaecological Oncological Trial groups
D9311C00001	Other Identifier	AZ DCode
2022-502746-27-00	Registry Identifier	CTIS (EU)
2019-004112-60	EudraCT Number

Name	Class
GOG Foundation	NETWORK
European Network of Gynaecological Oncological Trial Groups (ENGOT)	OTHER

Label	Type	Description	Intervention Names
Arm A (control)	Active Comparator	Platinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets).	Drug: durvalumab placebo Drug: olaparib placebo Drug: Carboplatin Drug: Paclitaxel
Arm B (durvalumab+placebo)	Experimental	Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo	Biological: durvalumab Drug: olaparib placebo Drug: Carboplatin Drug: Paclitaxel
Arm C (durvalumab+olaparib)	Experimental	Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib.	Drug: olaparib Biological: durvalumab Drug: Carboplatin Drug: Paclitaxel

Name	Type	Description	Arm Group Labels	Other Names
olaparib	Drug	Olaparib tablets	Arm C (durvalumab+olaparib)
durvalumab

Measure	Description	Time Frame
Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments	To demonstrate the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy by assessment of PFS (using investigator assessment according to Response Evaluation Criteria in Solid Tumours version 1.1 [RECIST 1.1]) in patients with newly diagnosed advanced or recurrent endometrial cancer	At baseline, every 9 weeks (wks) up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO (08 Jul 2024 DCO for China cohort), up to 50 months

Measure	Description	Time Frame
Overall Survival (OS) Analysis	To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of OS	Survival assessed every 2 months after RECIST defined radiological progression; assessed through study completion, up to 83 months

Name	Affiliation	Role
Shannon N. Westin, MD, MPH, FACOG	M.D. Anderson Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Tucson	Arizona	85719	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
41943281	Derived	Westin SN, Moore K, Chon HS, Lee JY, Thomes Pepin J, Sundborg M, Shai A, de la Garza J, Nishio S, Gold MA, Wang K, McIntyre K, Tillmanns TD, Blank SV, Liu JH, McCollum M, Contreras Mejia F, Nishikawa T, Pennington K, Novak Z, De Melou AC, Sehouli J, Klasa-Mazurkiewicz D, Papadimitriou C, Gil-Martin M, Brasiuniene B, Donnelly C, Liu X, Nieuwenhuysen EV; DUO-E Investigators. Plain language summary of results from the DUO-E study: durvalumab given with or without olaparib in patients with advanced endometrial cancer. Future Oncol. 2026 Apr;22(9):1031-1046. doi: 10.1080/14796694.2026.2638677. Epub 2026 Apr 6.
40590327

Label	URL
Redacted Statistical Analysis Plan	View source

ID	Title	Description
FG000	Standard of Care (SoC)	Platinum-based chemotherapy (paclitaxel and carboplatin) every 3 weeks (Q3W) for a maximum of 6 cycles with durvalumab placebo (intravenous [IV]) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) every 4 weeks (Q4W) and olaparib placebo (tablets) twice daily (bd) orally as maintenance treatment until disease progression.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 24, 2023	Jul 2, 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) According to RECIST 1.1, Based on Investigator Assessments

To demonstrate the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy by assessment of PFS (using investigator assessment according to Response Evaluation Criteria in Solid Tumours version 1.1 [RECIST 1.1]) in patients with newly diagnosed advanced or recurrent endometrial cancer

Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). China FAS includes all patients who were randomised at sites in China and Hong Kong.

Posted

Median

95% Confidence Interval

Months

At baseline, every 9 weeks (wks) up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO (08 Jul 2024 DCO for China cohort), up to 50 months

ID	Title	Description
OG000	Global Cohort - SoC	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
OG001	Global Cohort - SoC + Durvalumab	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
OG002	Global Cohort - SoC + Durvalumab + Olaparib	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
OG003	China Cohort - SoC	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
OG004	China Cohort - SoC + Durvalumab	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
OG005	China Cohort - SoC + Durvalumab + Olaparib	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.

Units	Counts
Participants	OG000241 OG001238 OG002239 OG003

Title

Denominators

Categories

Title	Measurements
	OG0009.6(9.0 to 9.9) OG00110.2(9.7 to 14.7) OG00215.1(12.6 to 20.7) OG003

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		Regression, Cox	Model was stratified by MMR status (proficient versus deficient) and disease status (recurrent versus newly diagnosed).	0.003	Determined using a log-rank test stratified by mismatch repair (MMR) status (proficient versus deficient) and disease status (recurrent versus newly diagnosed).	Hazard Ratio (HR)	0.71			2-Sided	95	0.57	0.89			A hazard ratio less than 1 favours SoC + Durvalumab.		Superiority

Secondary

Overall Survival (OS) Analysis

To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of OS

Not Posted

Jun 2027

Survival assessed every 2 months after RECIST defined radiological progression; assessed through study completion, up to 83 months

Participants

Secondary

Time From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice

FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). China FAS includes all patients who were randomised at sites in China and Hong Kong.

Posted

Median

95% Confidence Interval

Months

At baseline, every 9 to 18 wks, then every 12 wks until objective radiological disease progression. Assessments then per local practice every 12 wks until second progression. Assessed until 12Apr2023 DCO (08Jul2024 DCO for China cohort), up to 50 months

ID	Title	Description
OG000	Global Cohort - SoC	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
OG001	Global Cohort - SoC + Durvalumab	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.

Secondary

Objective Response Rate (ORR) Based on Investigator Assessment

All participants with measurable disease at baseline were included in the analysis. FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). China FAS includes all patients who were randomised at sites in China and Hong Kong. Odds ratio only calculated for Global cohort (per statistical analysis plan [SAP]).

Posted

Number

Percentage of participants

At baseline, every 9 to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO (08 Jul 2024 DCO for China cohort), up to 50 months

ID	Title	Description
OG000	Global Cohort - SoC	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
OG001	Global Cohort - SoC + Durvalumab

Secondary

Duration of Response (DoR) Based on Investigator Assessment

All participants with confirmed response were included in the analysis. FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). This endpoint was not assessed in the China cohort as it was not prespecified in the statistical analysis plan (SAP).

Posted

Median

Inter-Quartile Range

Months

At baseline, every 9 wks up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO, up to 35 months

ID	Title	Description
OG000	Global Cohort - SoC	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
OG001	Global Cohort - SoC + Durvalumab	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.

Secondary

Time From Randomisation to First Subsequent Therapy or Death (TFST)

Not Posted

Jun 2027

Time elapsed from randomisation to first subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months)

Participants

Secondary

Time From Randomisation to Second Subsequent Therapy or Death (TSST)

Not Posted

Jun 2027

Time elapsed from randomisation to second subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months)

Participants

Secondary

Time From Randomisation to Discontinuation of Treatment or Death (TDT)

Not Posted

Jun 2027

Time elapsed from randomisation to study treatment discontinuation or death. Assessed through study completion, up to 83 months

Participants

Secondary

Serum Concentration of Durvalumab

To characterise the pharmacokinetics (PK) of durvalumab and durvalumab in combination with olaparib

The Overall Number of Participants Analyzed reflects the total number of patients included in the PK Analysis Set, which comprises those treated with durvalumab per protocol and with valid PK data. However, PK concentrations were excluded at the sample level if they do not meet protocol-defined criteria. While some patients may not have any valid samples due to these exclusions, they remain part of the analysis population set by definition.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

PK sampling performed on Day 85 pre-dose, Day 183 pre-dose, and 3 months after study treatment discontinuation (up to 36 months)

ID	Title	Description
OG000	Global Cohort - SoC + Durvalumab	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
OG001	Global Cohort - SoC + Durvalumab + Olaparib	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.

Secondary

Anti-drug Antibodies (ADA) to Durvalumab

To characterise the immunogenicity of durvalumab and durvalumab in combination with olaparib

ADA Analysis Set. This includes all patients who receive at least 1 dose of durvalumab and have non-missing baseline ADA and at least 1 post-baseline ADA result.

Posted

Number

Number of participants

Immunogenicity sampling performed on Day 1 pre-dose, Day 85 pre-dose, Day 183 pre-dose, and 3 and 6 months after study treatment discontinuation (up to 39 months)

ID	Title	Description
OG000	Global Cohort - SoC + Durvalumab	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
OG001	Global Cohort - SoC + Durvalumab + Olaparib	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
OG002

Secondary

Change From Baseline in Physical Functioning Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients 30 (EORTC QLQ-C30)

To determine effects on symptoms, functioning, and overall health related quality of life (HRQoL) of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy alone in newly diagnosed advanced or recurrent endometrial cancer patients. The physical functioning score is a score from 0 to 100. Higher scores on the physical functioning score indicate better health status/function.

FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). All participants with a baseline and post baseline physical functioning score available were analysed. This endpoint was not assessed in the China cohort as it was not prespecified in the SAP.

Posted

Least Squares Mean

Standard Error

Score on a scale

At baseline, every 3 wks until Wk 18, and every 4 wks until the second progression. Assessed until 12 Apr 2023 DCO, up to 35 months. The average treatment effect over the first 12 months after randomisation is presented.

ID	Title	Description
OG000	Global Cohort - SoC	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.

Secondary

Change From Baseline in Global Health Status/QoL Score of the EORTC QLQ-C30

To determine effects on symptoms, functioning, and overall HRQoL of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy alone in newly diagnosed advanced or recurrent endometrial cancer patients. The global health status/quality of life (QoL) is a score from 0 to 100. Higher scores on the global health status/QoL indicate better health status/function.

FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). All participants with a baseline and post baseline global health status/QoL available were analysed. This endpoint was not assessed in the China cohort as it was not prespecified in the SAP.

Posted

Least Squares Mean

Standard Error

Score on a scale

ID	Title	Description
OG000	Global Cohort - SoC	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG0031 events1 affected44 at risk EG0040 events0 affected41 at risk EG0050 events0 affected41 at risk
Lung abscess	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Neutropenic infection	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Neutropenic sepsis	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0012 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Paracancerous pneumonia	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Pelvic infection	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Peritonitis	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Pneumonia	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0022 events2 affected238 at risk EG003
Pneumonia aspiration	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Pseudomembranous colitis	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Myelosuppression	Blood and lymphatic system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0022 events2 affected238 at risk EG003
Psoas abscess	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0012 events2 affected235 at risk EG0020 events0 affected238 at risk EG003
Retroperitoneal abscess	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Sepsis	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0003 events3 affected236 at risk EG0012 events2 affected235 at risk EG0025 events4 affected238 at risk EG003
Septic shock	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0002 events2 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0005 events5 affected236 at risk EG0012 events2 affected235 at risk EG0026 events6 affected238 at risk EG003
Urinary tract infection enterococcal	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Urosepsis	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0003 events3 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0003 events3 affected236 at risk EG0013 events3 affected235 at risk EG0025 events5 affected238 at risk EG003
West nile viral infection	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 25.1, 27.0	Systematic Assessment	EG0003 events3 affected236 at risk EG0011 events1 affected235 at risk EG0021 events1 affected238 at risk EG003
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 25.1, 27.0	Systematic Assessment	EG0004 events3 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Amylase increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0022 events2 affected238 at risk EG003
Creatinine renal clearance decreased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
International normalised ratio increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Liver function test abnormal	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0004 events4 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Occult blood	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Platelet count decreased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0021 events1 affected238 at risk EG003
White blood cell count decreased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Adult failure to thrive	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0003 events2 affected236 at risk EG0011 events1 affected235 at risk EG0023 events2 affected238 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0022 events2 affected238 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0005 events4 affected236 at risk EG0015 events5 affected235 at risk EG0020 events0 affected238 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Starvation ketoacidosis	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Colorectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Left ventricular failure	Cardiac disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0011 events1 affected235 at risk EG0021 events1 affected238 at risk EG003
Dizziness	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Dyskinesia	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0021 events1 affected238 at risk EG003
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00017 events10 affected236 at risk EG0011 events1 affected235 at risk EG00233 events16 affected238 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Meralgia paraesthetica	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Myxoedema coma	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Presyncope	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Secondary cerebellar degeneration	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Speech disorder	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0022 events1 affected238 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Syncope	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0021 events1 affected238 at risk EG003
Tremor	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Completed suicide	Psychiatric disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Delirium	Psychiatric disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Depression	Psychiatric disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0002 events2 affected236 at risk EG0011 events1 affected235 at risk EG0022 events2 affected238 at risk EG003
Cystitis noninfective	Renal and urinary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0002 events2 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0002 events2 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Renal infarct	Renal and urinary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Ureteric obstruction	Renal and urinary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Female genital tract fistula	Reproductive system and breast disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0012 events2 affected235 at risk EG0020 events0 affected238 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0021 events1 affected238 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0023 events3 affected238 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0004 events4 affected236 at risk EG0010 events0 affected235 at risk EG0023 events3 affected238 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Dermatomyositis	Skin and subcutaneous tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Euthyroid sick syndrome	Endocrine disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0012 events2 affected235 at risk EG0020 events0 affected238 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0012 events2 affected235 at risk EG0020 events0 affected238 at risk EG003
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0012 events2 affected235 at risk EG0023 events3 affected238 at risk EG003
Embolism	Vascular disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Embolism venous	Vascular disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Hypertension	Vascular disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0002 events1 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Hypotension	Vascular disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Lymphoedema	Vascular disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Peripheral artery thrombosis	Vascular disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Thrombosis	Vascular disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Secondary adrenocortical insufficiency	Endocrine disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Aplasia pure red cell	Blood and lymphatic system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0023 events3 affected238 at risk EG003
Cataract	Eye disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Retinal detachment	Eye disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Anal haemorrhage	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0021 events1 affected238 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0012 events2 affected235 at risk EG0021 events1 affected238 at risk EG003
Colonic fistula	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0003 events3 affected236 at risk EG0012 events2 affected235 at risk EG0020 events0 affected238 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0004 events4 affected236 at risk EG0010 events0 affected235 at risk EG0022 events2 affected238 at risk EG003
Duodenal stenosis	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0008 events8 affected236 at risk EG0014 events4 affected235 at risk EG0028 events7 affected238 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Faecal vomiting	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Faecaloma	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0012 events2 affected235 at risk EG0020 events0 affected238 at risk EG003
Gastric perforation	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0002 events2 affected236 at risk EG0012 events2 affected235 at risk EG0020 events0 affected238 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0021 events1 affected238 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0002 events2 affected236 at risk EG0013 events3 affected235 at risk EG0021 events1 affected238 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0025 events1 affected238 at risk EG003
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0002 events2 affected236 at risk EG0015 events5 affected235 at risk EG0021 events1 affected238 at risk EG003
Asthenia	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0011 events1 affected235 at risk EG0022 events2 affected238 at risk EG003
Death	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0002 events2 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Fatigue	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
General physical health deterioration	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Hyperplasia	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Immune thrombocytopenia	Blood and lymphatic system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Malaise	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0021 events1 affected238 at risk EG003
Oedema peripheral	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Pain	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Pyrexia	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0011 events1 affected235 at risk EG0024 events3 affected238 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0021 events1 affected238 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Immune-mediated cholangitis	Hepatobiliary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Immune-mediated hepatic disorder	Hepatobiliary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Portal hypertension	Hepatobiliary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Anaphylactic shock	Immune system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0021 events1 affected238 at risk EG003
Contrast media allergy	Immune system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Abdominal infection	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Abscess limb	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Appendicitis	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Covid-19	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0003 events3 affected236 at risk EG0011 events1 affected235 at risk EG0024 events4 affected238 at risk EG003
Covid-19 pneumonia	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0023 events3 affected238 at risk EG003
Cellulitis	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Cholecystitis infective	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Hepatitis c	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Herpes virus infection	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003
Intervertebral discitis	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0021 events1 affected238 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0025 events5 affected238 at risk EG0030 events0 affected44 at risk EG0042 events2 affected41 at risk EG0053 events3 affected41 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG0008 events8 affected236 at risk EG0015 events4 affected235 at risk EG00212 events11 affected238 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG00065 events47 affected236 at risk EG00162 events32 affected235 at risk EG00267 events46 affected238 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00048 events30 affected236 at risk EG00161 events34 affected235 at risk EG00285 events47 affected238 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 25.1, 27.0	Systematic Assessment	EG00010 events10 affected236 at risk EG00114 events14 affected235 at risk EG00219 events15 affected238 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 25.1, 27.0	Systematic Assessment	EG00028 events22 affected236 at risk EG00119 events14 affected235 at risk EG00217 events12 affected238 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG00024 events18 affected236 at risk EG00137 events30 affected235 at risk EG00241 events30 affected238 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG00026 events17 affected236 at risk EG00126 events22 affected235 at risk EG00225 events20 affected238 at risk EG003
Bile acids increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0008 events6 affected236 at risk EG00113 events11 affected235 at risk EG0029 events8 affected238 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0007 events4 affected236 at risk EG0017 events4 affected235 at risk EG0020 events0 affected238 at risk EG003
Blood creatinine increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG00020 events13 affected236 at risk EG00113 events10 affected235 at risk EG00242 events24 affected238 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG00019 events14 affected236 at risk EG00115 events9 affected235 at risk EG00214 events8 affected238 at risk EG003
Blood pressure increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0022 events2 affected238 at risk EG003
Blood thyroid stimulating hormone decreased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0015 events4 affected235 at risk EG0024 events3 affected238 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0005 events4 affected236 at risk EG0013 events3 affected235 at risk EG0027 events4 affected238 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00030 events18 affected236 at risk EG00149 events30 affected235 at risk EG00270 events35 affected238 at risk EG003
Blood urea increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0006 events4 affected236 at risk EG0013 events3 affected235 at risk EG0024 events3 affected238 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG00014 events12 affected236 at risk EG00117 events17 affected235 at risk EG00222 events15 affected238 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG00012 events5 affected236 at risk EG0011 events1 affected235 at risk EG00211 events4 affected238 at risk EG003
Lipase increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG00012 events11 affected236 at risk EG0018 events7 affected235 at risk EG0026 events5 affected238 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG00021 events12 affected236 at risk EG00117 events11 affected235 at risk EG00217 events12 affected238 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG000159 events60 affected236 at risk EG001105 events43 affected235 at risk EG002145 events50 affected238 at risk EG003
Neutrophil count increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0006 events1 affected236 at risk EG0012 events2 affected235 at risk EG0020 events0 affected238 at risk EG003
Platelet count decreased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG00073 events37 affected236 at risk EG00161 events36 affected235 at risk EG00271 events39 affected238 at risk EG003
Weight decreased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG00028 events23 affected236 at risk EG00124 events20 affected235 at risk EG00217 events17 affected238 at risk EG003
Weight increased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0007 events7 affected236 at risk EG0017 events7 affected235 at risk EG00212 events10 affected238 at risk EG003
White blood cell count decreased	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG000111 events40 affected236 at risk EG00167 events29 affected235 at risk EG002112 events38 affected238 at risk EG003
White blood cells urine positive	Investigations	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG00212 events1 affected238 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00060 events46 affected236 at risk EG00157 events42 affected235 at risk EG00283 events55 affected238 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0011 events1 affected235 at risk EG0020 events0 affected238 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00025 events18 affected236 at risk EG00112 events8 affected235 at risk EG00219 events17 affected238 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00011 events8 affected236 at risk EG0016 events5 affected235 at risk EG0029 events7 affected238 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0003 events1 affected236 at risk EG0013 events3 affected235 at risk EG0023 events3 affected238 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0003 events3 affected236 at risk EG0014 events3 affected235 at risk EG0020 events0 affected238 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0004 events4 affected236 at risk EG0019 events9 affected235 at risk EG00217 events10 affected238 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0006 events5 affected236 at risk EG0018 events5 affected235 at risk EG0022 events2 affected238 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00037 events20 affected236 at risk EG00142 events26 affected235 at risk EG00249 events27 affected238 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00053 events38 affected236 at risk EG00149 events38 affected235 at risk EG00266 events38 affected238 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00017 events9 affected236 at risk EG00111 events8 affected235 at risk EG00222 events12 affected238 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0004 events3 affected236 at risk EG0013 events3 affected235 at risk EG0023 events3 affected238 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00089 events58 affected236 at risk EG001112 events70 affected235 at risk EG00298 events58 affected238 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00033 events22 affected236 at risk EG00123 events19 affected235 at risk EG00239 events35 affected238 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00025 events22 affected236 at risk EG00119 events16 affected235 at risk EG00216 events11 affected238 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00016 events12 affected236 at risk EG00110 events7 affected235 at risk EG0029 events8 affected238 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00019 events15 affected236 at risk EG00117 events15 affected235 at risk EG00217 events13 affected238 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00073 events44 affected236 at risk EG00147 events32 affected235 at risk EG00233 events30 affected238 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00042 events35 affected236 at risk EG00144 events31 affected235 at risk EG00238 events29 affected238 at risk EG003
Dizziness	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00038 events30 affected236 at risk EG00137 events32 affected235 at risk EG00250 events40 affected238 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00027 events26 affected236 at risk EG00128 events24 affected235 at risk EG00233 events27 affected238 at risk EG003
Headache	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00042 events35 affected236 at risk EG00134 events30 affected235 at risk EG00249 events39 affected238 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00019 events12 affected236 at risk EG00110 events9 affected235 at risk EG00219 events15 affected238 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG000160 events121 affected236 at risk EG001168 events111 affected235 at risk EG002242 events141 affected238 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00083 events66 affected236 at risk EG00169 events61 affected235 at risk EG00274 events60 affected238 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00011 events10 affected236 at risk EG00114 events13 affected235 at risk EG0029 events6 affected238 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00074 events66 affected236 at risk EG00169 events60 affected235 at risk EG00266 events60 affected238 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00035 events33 affected236 at risk EG00128 events24 affected235 at risk EG00231 events29 affected238 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0000 events0 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00016 events12 affected236 at risk EG00112 events10 affected235 at risk EG00211 events10 affected238 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00011 events11 affected236 at risk EG0014 events4 affected235 at risk EG0028 events7 affected238 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00015 events15 affected236 at risk EG0013 events3 affected235 at risk EG00211 events9 affected238 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0010 events0 affected235 at risk EG0020 events0 affected238 at risk EG003
Vaginal discharge	Reproductive system and breast disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0007 events4 affected236 at risk EG0015 events4 affected235 at risk EG00213 events13 affected238 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00015 events13 affected236 at risk EG00112 events11 affected235 at risk EG0029 events9 affected238 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00031 events25 affected236 at risk EG00138 events35 affected235 at risk EG00240 events32 affected238 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00029 events25 affected236 at risk EG00134 events27 affected235 at risk EG00236 events29 affected238 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG000118 events118 affected236 at risk EG001122 events118 affected235 at risk EG002124 events121 affected238 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00041 events29 affected236 at risk EG00142 events36 affected235 at risk EG00258 events37 affected238 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00032 events27 affected236 at risk EG00159 events41 affected235 at risk EG00238 events28 affected238 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0007 events6 affected236 at risk EG00116 events13 affected235 at risk EG00223 events15 affected238 at risk EG003
Hypertension	Vascular disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00018 events13 affected236 at risk EG00110 events10 affected235 at risk EG00227 events13 affected238 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0004 events4 affected236 at risk EG00116 events15 affected235 at risk EG00215 events13 affected238 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0009 events8 affected236 at risk EG00144 events37 affected235 at risk EG00242 events33 affected238 at risk EG003
Vision blurred	Eye disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00010 events10 affected236 at risk EG00115 events12 affected235 at risk EG0029 events9 affected238 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00012 events11 affected236 at risk EG00117 events10 affected235 at risk EG00215 events13 affected238 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00039 events38 affected236 at risk EG00149 events38 affected235 at risk EG00253 events40 affected238 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00013 events13 affected236 at risk EG0019 events8 affected235 at risk EG0027 events6 affected238 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00012 events10 affected236 at risk EG00117 events16 affected235 at risk EG00216 events14 affected238 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG000102 events80 affected236 at risk EG00180 events63 affected235 at risk EG002105 events78 affected238 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG000101 events64 affected236 at risk EG001115 events74 affected235 at risk EG002114 events67 affected238 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0005 events5 affected236 at risk EG0015 events5 affected235 at risk EG00214 events9 affected238 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00021 events18 affected236 at risk EG00113 events12 affected235 at risk EG00228 events22 affected238 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG000182 events105 affected236 at risk EG001157 events95 affected235 at risk EG002237 events129 affected238 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00024 events18 affected236 at risk EG00120 events19 affected235 at risk EG00231 events25 affected238 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0001 events1 affected236 at risk EG0018 events7 affected235 at risk EG0024 events4 affected238 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00072 events42 affected236 at risk EG00173 events46 affected235 at risk EG00293 events61 affected238 at risk EG003
Asthenia	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00034 events23 affected236 at risk EG00131 events22 affected235 at risk EG00272 events44 affected238 at risk EG003
Chest discomfort	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0005 events4 affected236 at risk EG0014 events4 affected235 at risk EG0027 events5 affected238 at risk EG003
Fatigue	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG000127 events87 affected236 at risk EG001101 events82 affected235 at risk EG002143 events93 affected238 at risk EG003
Influenza like illness	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0009 events8 affected236 at risk EG00114 events10 affected235 at risk EG0029 events9 affected238 at risk EG003
Malaise	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00021 events16 affected236 at risk EG00131 events14 affected235 at risk EG00218 events12 affected238 at risk EG003
Oedema peripheral	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00023 events21 affected236 at risk EG00135 events29 affected235 at risk EG00237 events30 affected238 at risk EG003
Pain	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00014 events9 affected236 at risk EG0016 events6 affected235 at risk EG00214 events10 affected238 at risk EG003
Peripheral swelling	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0006 events6 affected236 at risk EG0018 events8 affected235 at risk EG00212 events10 affected238 at risk EG003
Pyrexia	General disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00020 events18 affected236 at risk EG00127 events20 affected235 at risk EG00230 events23 affected238 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG0006 events3 affected236 at risk EG0014 events4 affected235 at risk EG0022 events1 affected238 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 25.1, 27.0	Systematic Assessment	EG00014 events9 affected236 at risk EG00125 events12 affected235 at risk EG00237 events15 affected238 at risk EG003
Covid-19	Infections and infestations	MedDRA 25.1, 27.0	Systematic Assessment	EG00029 events29 affected236 at risk EG00136 events35 affected235 at risk EG00246 events44 affected238 at risk EG003

ID	Title	Description
BG000	SoC (Global Cohort & China Cohort)	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
BG001	SoC + Durvalumab (Global Cohort & China Cohort)	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
BG002	SoC + Durvalumab + Olaparib (Global Cohort & China Cohort)	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
BG003	Total	Total of all reporting groups

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Global Cohort - SoC	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.	82	241	73	236	233	236
EG001	Global Cohort - SoC + Durvalumab	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.	65	238	73	235	228	235
EG002	Global Cohort - SoC + Durvalumab + Olaparib	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.	52	239	85	238	236	238
EG003	China Cohort - SoC	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.	12	44	14	44	44	44
EG004	China Cohort - SoC + Durvalumab	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.	11	43	8	41	41	41
EG005	China Cohort - SoC + Durvalumab + Olaparib	Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.	14	42	19	41	39	41

ID	Term
C531550	olaparib
C000613593	durvalumab
D016190	Carboplatin
D017239	Paclitaxel