Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment)... | NCT03732677

ID	Type	Description	Link
2023-510015-19-00	Registry Identifier	CTIS
2018-001811-59	EudraCT Number

Label	Type	Description	Intervention Names
Arm 1	Experimental	Chemotherapy + Durvalumab	Drug: Durvalumab Drug: Cisplatin Drug: Gemcitabine
Arm 2	Active Comparator	Chemotherapy alone	Drug: Cisplatin Drug: Gemcitabine

Name	Type	Description	Arm Group Labels	Other Names
Durvalumab	Drug	Anti- PD-L1 Antibody	Arm 1
Cisplatin

Measure	Description	Time Frame
Pathologic Complete Response (pCR) Rates at Time of Cystectomy	pCR rate is defined as the proportion of patients whose pathological staging was T0N0M0 as assessed per central pathology review using specimens obtained via radical cystectomy following the neoadjuvant treatment. The denominator for pCR will be the number of patients in the FAS.	Up to 6 months
Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event	EFS is defined as the time from randomization to the first recurrence of disease post radical cystectomy, time of first documented progression in patients who were medically precluded for radical cystectomy, or time of expected surgery in patients who refuse to undergo a radical cystectomy or failure to undergo a radical cystectomy in participants with residual disease, or the time of death due to any cause, whichever occurs first	Up to 48 months

Measure	Description	Time Frame
Event-free Survival at 24 Months (EFS24) Per Central Review Defined as Time From Randomization to Event	EFS24 is defined as the Kaplan-Meier estimate of EFS at 24 months after randomization, as assessed per blinded independent central review or by central pathology review if a biopsy is required for a suspected new lesion, and per local investigator or local biopsy review if a biopsy is required for a suspected new lesion

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35294	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
39282910	Derived	Powles T, Catto JWF, Galsky MD, Al-Ahmadie H, Meeks JJ, Nishiyama H, Vu TQ, Antonuzzo L, Wiechno P, Atduev V, Kann AG, Kim TH, Suarez C, Chang CH, Roghmann F, Ozguroglu M, Eigl BJ, Oliveira N, Buchler T, Gadot M, Zakharia Y, Armstrong J, Gupta A, Hois S, van der Heijden MS; NIAGARA Investigators. Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer. N Engl J Med. 2024 Nov 14;391(19):1773-1786. doi: 10.1056/NEJMoa2408154. Epub 2024 Sep 15.

Label	URL
D933RC00001\_CSR synopsis\_Redacted	View source

ID	Title	Description
FG000	Durvalumab + Gemcitabine + Cisplatin	Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 29, 2024	Jun 17, 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

Pathologic Complete Response (pCR) Rates at Time of Cystectomy

pCR rate is defined as the proportion of patients whose pathological staging was T0N0M0 as assessed per central pathology review using specimens obtained via radical cystectomy following the neoadjuvant treatment. The denominator for pCR will be the number of patients in the FAS.

Full Analysis Set (Intention to Treat): includes all randomized subjects

Posted

Count of Participants

Participants

Up to 6 months

ID	Title	Description
OG000	Durvalumab + Gemcitabine + Cisplatin	Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
OG001	Gemcitabine + Cisplatin	Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function

Units	Counts
Participants	OG000533 OG001530

Title

Denominators

Categories

Title	Measurements
	OG000199 OG001146

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, Logistic	Strata adjusted odds ratio by the logistic regression method adjusting for stratification factors: renal function , tumor stage and PDL1 status .	0.0005		Odds Ratio (OR)	1.60			2-Sided	95	1.227	2.084					Superiority

Primary

Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event

EFS is defined as the time from randomization to the first recurrence of disease post radical cystectomy, time of first documented progression in patients who were medically precluded for radical cystectomy, or time of expected surgery in patients who refuse to undergo a radical cystectomy or failure to undergo a radical cystectomy in participants with residual disease, or the time of death due to any cause, whichever occurs first

The full analysis set (FAS) includes all randomized patients

Posted

Median

Inter-Quartile Range

months

Up to 48 months

ID	Title	Description
OG000	Durvalumab + Gemcitabine + Cisplatin	Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
OG001	Gemcitabine + Cisplatin	Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function

Secondary

Event-free Survival at 24 Months (EFS24) Per Central Review Defined as Time From Randomization to Event

EFS24 is defined as the Kaplan-Meier estimate of EFS at 24 months after randomization, as assessed per blinded independent central review or by central pathology review if a biopsy is required for a suspected new lesion, and per local investigator or local biopsy review if a biopsy is required for a suspected new lesion

The full analysis set (FAS) Intention to treat included all randomized patients

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 24 months

ID	Title	Description
OG000	Durvalumab + Gemcitabine + Cisplatin	Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
OG001	Gemcitabine + Cisplatin	Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function

Secondary

Proportion of Patients Who Undergo Cystectomy

The proportion of patients who undergo cystectomy is defined as the proportion patients who undergo radical cystectomy after the neoadjuvant treatment. The denominator will be patients in the FAS.

The full analysis set (FAS) Intention to treat included all randomized patients.

Posted

Count of Participants

Participants

Up to 6 months

ID	Title	Description
OG000	Durvalumab + Gemcitabine + Cisplatin	Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
OG001	Gemcitabine + Cisplatin	Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function

Units	Counts
Participants

Secondary

Overall Survival

OS is defined as the time from the date of randomization until death due to any cause regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy (i.e., date of death or censoring - date of randomization + 1)

Posted

Median

Inter-Quartile Range

Months

Up to 65 months

ID	Title	Description
OG000	Durvalumab+Gemcitabine+Cisplatin	Durvalumab + Gemcitabine + Cisplatin Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
OG001	Gemcitabine+Cisplatin	Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function

Units	Counts
Participants

Secondary

Metastasis-free Survival Per Investigator Assessment or Local Biopsy Review.

MFS is defined as the time from date of randomization until the first recognition of distant metastases or death, whichever occurs first

The full analysis set (FAS) Intention to treat included all randomized patients.

Posted

Median

Inter-Quartile Range

Months

Up to 48 months

ID	Title	Description
OG000	Durvalumab + Gemcitabine + Cisplatin	Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
OG001	Gemcitabine + Cisplatin	Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function

Units	Counts
Participants

Secondary

Disease-specific Survival Per Investigator Assessment or Local Biopsy Review.

DSS is defined as the time from the date of randomization until death due to bladder cancer

The full analysis set (FAS) Intention to treat included all randomized patients.

Posted

Median

Inter-Quartile Range

months

Up to 48 months

ID	Title	Description
OG000	Durvalumab + Gemcitabine + Cisplatin	Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
OG001	Gemcitabine + Cisplatin	Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function

Units	Counts
Participants

Secondary

Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA)

Whole blood samples for assessing ADA for durvalumab in serum were collected from patients undergoing durvalumab treatment, following the specified assessment schedule. ADA prevalence is the proportion of patients with a positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA includes both treatment-induced and treatment-boosted ADA. Its incidence is the proportion of patients with treatment-emergent ADA positivity. Treatment-boosted ADA refers to a baseline-positive ADA titer that increased ≥4-fold during the study. Persistently positive patients have at least two post-baseline ADA-positive readings, with at least 16 weeks between the first and last, or an ADA-positive result at the final assessment. This includes baseline-positive patients meeting these criteria. Transiently positive is defined by at least one post-baseline ADA-positive reading without being persistently positive, including baseline-positive patients meeting these terms.

The ADA analysis set includes all participants who had non-missing baseline ADA and at least one non-missing post-baseline ADA result.

Posted

Count of Participants

Participants

Up to 12 months

ID	Title	Description
OG000	Durvalumab + Gemcitabine + Cisplatin	Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0012 events2 affected526 at risk
Catheter site infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Cellulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected530 at risk EG0010 events0 affected526 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Cystitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0012 events1 affected526 at risk
Dengue fever	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Device related infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0010 events0 affected526 at risk
Diverticulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Endocarditis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0012 events2 affected526 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0010 events0 affected526 at risk
Erysipelas	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Escherichia infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Escherichia sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Fungaemia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Fungal endocarditis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Fungal peritonitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Gastroenteritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Haematological infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Infected lymphocele	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0010 events0 affected526 at risk
Cardiac arrest	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0011 events1 affected526 at risk
Influenza	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Kidney infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0012 events2 affected526 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Osteomyelitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Pelvic abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Pelvic infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Perineal abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Perinephric abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Peritonitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00012 events12 affected530 at risk EG0016 events5 affected526 at risk
Cardiac failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0012 events2 affected526 at risk
Pneumonia aspiration	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0010 events0 affected526 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Pneumonia parainfluenzae viral	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Post procedural infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Postoperative abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0012 events2 affected526 at risk
Postoperative wound infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0011 events1 affected526 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Pyelonephritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00026 events19 affected530 at risk EG00128 events23 affected526 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0007 events6 affected530 at risk EG0014 events4 affected526 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected530 at risk EG0011 events1 affected526 at risk
Retroperitoneal abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00020 events19 affected530 at risk EG00115 events14 affected526 at risk
Septic shock	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0008 events8 affected530 at risk EG0015 events5 affected526 at risk
Severe acute respiratory syndrome	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Staphylococcal infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Suspected covid-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Urethritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00080 events59 affected530 at risk EG00190 events69 affected526 at risk
Urosepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00022 events20 affected530 at risk EG00111 events10 affected526 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Wound infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected530 at risk EG0011 events1 affected526 at risk
Abdominal injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Abdominal wound dehiscence	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Anastomotic fistula	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0012 events2 affected526 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0012 events2 affected526 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0011 events1 affected526 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Post procedural fever	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0012 events1 affected526 at risk
Post procedural urine leak	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0012 events2 affected526 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected530 at risk EG0010 events0 affected526 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0012 events2 affected526 at risk
Rectal injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Stenosis of vesicourethral anastomosis	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Myocardial infarction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected530 at risk EG0012 events2 affected526 at risk
Stomal hernia	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Suture related complication	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Ureteric anastomosis complication	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected530 at risk EG0012 events2 affected526 at risk
Urethral injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Urinary tract injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Urostomy complication	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0012 events2 affected526 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected530 at risk EG0012 events2 affected526 at risk
Wound evisceration	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected530 at risk EG0010 events0 affected526 at risk
Blood creatinine increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected530 at risk EG0011 events1 affected526 at risk
C-reactive protein increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Candida test positive	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Gastrointestinal stoma output increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Hepatic enzyme increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Lymphocyte count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Neutrophil count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected530 at risk EG0013 events3 affected526 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Pancreatic enzymes increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0010 events0 affected526 at risk
Platelet count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected530 at risk EG0015 events5 affected526 at risk
Sars-cov-2 test positive	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
White blood cell count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0013 events3 affected526 at risk
Gout	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0006 events5 affected530 at risk EG00118 events17 affected526 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected530 at risk EG0010 events0 affected526 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0013 events2 affected526 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0011 events1 affected526 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0013 events2 affected526 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected530 at risk EG0011 events1 affected526 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Hamartoma	Congenital, familial and genetic disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0013 events3 affected526 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG00035 events35 affected530 at risk EG00127 events27 affected526 at risk
Prostate cancer stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected530 at risk EG0010 events0 affected526 at risk
Prostate cancer stage ii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG00021 events21 affected530 at risk EG00110 events10 affected526 at risk
Prostate cancer stage iii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0010 events0 affected526 at risk
Prostate cancer stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0010 events0 affected526 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Cerebral infarction	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0012 events2 affected526 at risk
Cerebral venous sinus thrombosis	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0013 events3 affected526 at risk
Cranial nerve palsies multiple	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Diabetic coma	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Dizziness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Embolic stroke	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Iiird nerve paralysis	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected530 at risk EG0012 events2 affected526 at risk
Seizure	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0012 events2 affected526 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Syncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected530 at risk EG0012 events2 affected526 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0010 events0 affected526 at risk
Hypopituitarism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Uraemic encephalopathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Device dislocation	Product Issues	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected530 at risk EG0011 events1 affected526 at risk
Device occlusion	Product Issues	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0012 events2 affected526 at risk
Agitation	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Completed suicide	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG00026 events25 affected530 at risk EG00129 events24 affected526 at risk
Anuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Bladder wall calcification	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0014 events4 affected526 at risk
Hypothyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Cystitis noninfective	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Haematuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0014 events3 affected526 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG00017 events15 affected530 at risk EG0018 events8 affected526 at risk
Immune-mediated nephritis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Nephritis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected530 at risk EG0011 events1 affected526 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0012 events2 affected526 at risk
Obstructive nephropathy	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Perinephric collection	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Renal failure	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0008 events8 affected530 at risk EG00110 events10 affected526 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0012 events1 affected526 at risk
Renal impairment	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected530 at risk EG0010 events0 affected526 at risk
Renal pelvis fistula	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0014 events3 affected526 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Urinary fistula	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Urinary retention	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected530 at risk EG0012 events2 affected526 at risk
Urinary tract disorder	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Urinary tract inflammation	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Thyroiditis	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected530 at risk EG0012 events2 affected526 at risk
Vesicourethral fistula	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Orchitis noninfective	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Pelvic fluid collection	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0012 events2 affected526 at risk
Prostatic dysplasia	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Vaginal fistula	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0010 events0 affected526 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0012 events2 affected526 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0012 events2 affected526 at risk
Autoimmune lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected530 at risk EG0011 events1 affected526 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0008 events8 affected530 at risk EG0019 events9 affected526 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0012 events2 affected526 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00018 events18 affected530 at risk EG0015 events5 affected526 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Abdominal hernia obstructive	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Aortic occlusion	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Arterioenteric fistula	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Circulatory collapse	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected530 at risk EG0014 events4 affected526 at risk
Distributive shock	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Embolism	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0006 events5 affected530 at risk EG0010 events0 affected526 at risk
Femoral artery embolism	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Hypertension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Hypotension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected530 at risk EG0012 events2 affected526 at risk
Lymphocele	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0007 events7 affected530 at risk EG0015 events5 affected526 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0012 events2 affected526 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0012 events1 affected526 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Superficial vein thrombosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Thrombophlebitis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Thrombosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Colitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0010 events0 affected526 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected530 at risk EG0010 events0 affected526 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0012 events2 affected526 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected530 at risk EG0011 events1 affected526 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Fistula of small intestine	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0012 events2 affected526 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0012 events2 affected526 at risk
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Hernial eventration	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0010 events0 affected526 at risk
Ileal perforation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Ileus	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0007 events7 affected530 at risk EG0014 events4 affected526 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected530 at risk EG0012 events2 affected526 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Inguinal hernia strangulated	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Intestinal fistula	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected530 at risk EG0015 events5 affected526 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Intestinal strangulation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0012 events2 affected526 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0014 events3 affected526 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0005 events4 affected530 at risk EG0012 events2 affected526 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0008 events6 affected530 at risk EG0012 events2 affected526 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Volvulus of small bowel	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events2 affected530 at risk EG0011 events1 affected526 at risk
Asthenia	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0016 events4 affected526 at risk
Death	General disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected530 at risk EG0015 events5 affected526 at risk
Dehiscence	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0014 events4 affected526 at risk
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
General physical health deterioration	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Hyperpyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Inflammation	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Malaise	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0012 events2 affected526 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0012 events2 affected526 at risk
Oedema peripheral	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected530 at risk EG0014 events4 affected526 at risk
Sudden cardiac death	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0010 events0 affected526 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Chronic hepatic failure	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Anaphylactic shock	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Abdominal abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected530 at risk EG0012 events2 affected526 at risk
Abdominal infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0012 events2 affected526 at risk
Arthritis bacterial	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Bacteraemia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected530 at risk EG0012 events2 affected526 at risk
Bacterial abdominal infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Bacterial sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk
Bacteroides bacteraemia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Bronchitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected530 at risk EG0011 events1 affected526 at risk
Covid-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0009 events9 affected530 at risk EG0015 events5 affected526 at risk
Covid-19 pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0011 events1 affected526 at risk
Candida infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected530 at risk EG0010 events0 affected526 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG000181 events124 affected530 at risk EG001158 events108 affected526 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG00049 events46 affected530 at risk EG00143 events38 affected526 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00065 events46 affected530 at risk EG00148 events38 affected526 at risk
Amylase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00043 events34 affected530 at risk EG00126 events19 affected526 at risk
Blood creatinine increased	Investigations	MedDRA 26.1	Systematic Assessment	EG000131 events94 affected530 at risk EG00197 events76 affected526 at risk
Lipase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00049 events39 affected530 at risk EG00132 events27 affected526 at risk
Neutrophil count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG000121 events80 affected530 at risk EG001102 events72 affected526 at risk
Platelet count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00048 events35 affected530 at risk EG00143 events32 affected526 at risk
Weight decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00041 events41 affected530 at risk EG00128 events27 affected526 at risk
White blood cell count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00047 events28 affected530 at risk EG00158 events35 affected526 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG000196 events140 affected530 at risk EG001175 events131 affected526 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG000257 events200 affected530 at risk EG001239 events200 affected526 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00033 events29 affected530 at risk EG00124 events23 affected526 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00058 events44 affected530 at risk EG00130 events26 affected526 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00047 events31 affected530 at risk EG00134 events23 affected526 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00077 events56 affected530 at risk EG00173 events55 affected526 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00065 events54 affected530 at risk EG00139 events35 affected526 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00057 events50 affected530 at risk EG00154 events46 affected526 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00035 events32 affected530 at risk EG00113 events13 affected526 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00027 events27 affected530 at risk EG00131 events28 affected526 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG00041 events36 affected530 at risk EG00148 events43 affected526 at risk
Dizziness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00059 events42 affected530 at risk EG00143 events39 affected526 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG00031 events30 affected530 at risk EG00110 events9 affected526 at risk
Dysgeusia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00042 events40 affected530 at risk EG00138 events33 affected526 at risk
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00074 events59 affected530 at risk EG00169 events59 affected526 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00040 events32 affected530 at risk EG00132 events29 affected526 at risk
Insomnia	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG00049 events43 affected530 at risk EG00156 events45 affected526 at risk
Hypothyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG00064 events60 affected530 at risk EG00111 events11 affected526 at risk
Dysuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG00033 events28 affected530 at risk EG00120 events19 affected526 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00029 events28 affected530 at risk EG00127 events23 affected526 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00040 events36 affected530 at risk EG00130 events24 affected526 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00055 events48 affected530 at risk EG00120 events19 affected526 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00066 events41 affected530 at risk EG00166 events50 affected526 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00050 events49 affected530 at risk EG00158 events57 affected526 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00096 events80 affected530 at risk EG00142 events38 affected526 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00081 events67 affected530 at risk EG00134 events30 affected526 at risk
Hypertension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG00071 events61 affected530 at risk EG00145 events42 affected526 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00080 events65 affected530 at risk EG00145 events39 affected526 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00038 events30 affected530 at risk EG00124 events22 affected526 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG000276 events204 affected530 at risk EG001276 events201 affected526 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG000137 events106 affected530 at risk EG00188 events74 affected526 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00055 events48 affected530 at risk EG00150 events47 affected526 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00052 events31 affected530 at risk EG00158 events37 affected526 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG000212 events136 affected530 at risk EG001274 events163 affected526 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG000425 events281 affected530 at risk EG001403 events254 affected526 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG000141 events101 affected530 at risk EG001138 events96 affected526 at risk
Asthenia	General disorders	MedDRA 26.1	Systematic Assessment	EG000119 events93 affected530 at risk EG001120 events92 affected526 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00075 events55 affected530 at risk EG00182 events55 affected526 at risk
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG000269 events190 affected530 at risk EG001225 events169 affected526 at risk
Malaise	General disorders	MedDRA 26.1	Systematic Assessment	EG00045 events34 affected530 at risk EG00132 events25 affected526 at risk
Oedema peripheral	General disorders	MedDRA 26.1	Systematic Assessment	EG00055 events45 affected530 at risk EG00152 events45 affected526 at risk
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG000140 events107 affected530 at risk EG001113 events84 affected526 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG00019 events18 affected530 at risk EG00132 events29 affected526 at risk
Covid-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00023 events21 affected530 at risk EG00131 events30 affected526 at risk

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

ID	Title	Description
BG000	Durvalumab + Gemcitabine + Cisplatin	Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
BG001	Gemcitabine + Cisplatin	Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
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	Durvalumab + Gemcitabine + Cisplatin	Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	27	533	326	530	522	530
EG001	Gemcitabine + Cisplatin	Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	29	526	287	526	511	526