Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azac... | NCT02785900

NCT02785900

ID	Type	Description	Link
2015-003482-28	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
33A + HMA	Experimental	33A plus azacitidine or decitabine	Drug: 33A Drug: azacitidine Drug: decitabine
placebo + HMA	Active Comparator	placebo plus azacitidine or decitabine	Drug: placebo Drug: azacitidine Drug: decitabine

Name	Type	Description	Arm Group Labels	Other Names
33A	Drug	33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push	33A + HMA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival	Time from randomization to death due to any cause	Up to 1.5 years
Composite Complete Remission (CRc) Rate	Number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) according to the modified response criteria for acute myeloid leukemia (AML) per Cheson 2003.	Up to 1.5 years

Secondary Outcomes

Measure	Description	Time Frame
Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate	Number of patients who achieve both remission (CR or CRi) and MRD-negative status	Up to 1.5 years
Duration of Remission

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Phoenix Ho, MD	Seagen Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas for Medical Sciences		Little Rock	Arkansas	72205	United States
City of Hope National Medical Center

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	33A + HMA	33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
FG001	Placebo + HMA

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Dec 4, 2017	Oct 1, 2018

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Duration of remission is calculated from the first documentation of CR or CRi to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.

Arm/Group Information

ID	Title	Description
BG000	33A + HMA	33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
BG001	Placebo + HMA	placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00075.0(62 to 91) BG00175.0(52 to 91) BG00275.0(52 to 91)

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Age Group

Title	Measurements
>65 years	BG0003 BG0013 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00069 BG00167 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0003 BG0012 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Hungary

Title	Measurements
	BG0005 BG0016 BG002

Eastern Cooperative Oncology Group (ECOG) Performance Status

0=Normal activity; 1=Symptoms but ambulatory; 2=In bed less than 50% of the time; 3= In bed more than 50% of the time; 4=100% bedridden; 5=Dead

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Grade 0: Normal activity	BG00023 BG001

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

Overall Survival

Time from randomization to death due to any cause

Intent-to-treat analysis set

Posted

Median

Inter-Quartile Range

months

Up to 1.5 years

ID	Title	Description
OG000	33A + HMA	33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
OG001	Placebo + HMA	placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks

Units	Counts
Participants	OG000117 OG001123

Title

Denominators

Categories

Title	Measurements
	OG0005.1(2.3 to 9.9) OG001NA(4.0 to NA)Insufficient number of participants with events

Primary

Composite Complete Remission (CRc) Rate

Number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) according to the modified response criteria for acute myeloid leukemia (AML) per Cheson 2003.

Intent-to-treat analysis set

Posted

Number

95% Confidence Interval

participants

Up to 1.5 years

ID	Title	Description
OG000	33A + HMA	33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
OG001	Placebo + HMA	placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks

Units	Counts
Participants	OG000

Secondary

Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate

Number of patients who achieve both remission (CR or CRi) and MRD-negative status

Intent-to-treat analysis set

Posted

Number

95% Confidence Interval

participants

Up to 1.5 years

ID	Title	Description
OG000	33A + HMA	33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
OG001	Placebo + HMA	placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks

Units	Counts
Participants	OG000

Secondary

Duration of Remission

Patients who achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi).

Posted

Median

Full Range

months

Up to approximately 9.5 months

ID	Title	Description
OG000	33A + HMA	33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
OG001	Placebo + HMA	placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks

Units	Counts

Secondary

Event-free Survival

Event-free survival is calculated from the time of randomization to the first documentation of progression, relapse, or death, whichever comes first. Patients who do not have event (progression, relapse, or death) prior to analysis cutoff date are censored at the date of last response assessment. Patients who started another anticancer therapy before progression, relapse, or death are censored at the date of last response assessment prior to the start of new therapy. Patients who do not have response assessment post-baseline are censored at the date of randomization.

Intent-to-treat analysis set

Posted

Median

95% Confidence Interval

months

Up to approximately 11.24 months

ID	Title	Description
OG000	33A + HMA	33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
OG001	Placebo + HMA	placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks

Secondary

Leukemia-free Survival

Leukemia-free survival is calculated from the first documentation of blast clearance (CR, CRi, mLFS) to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.

Patients who achieved CR/CRi

Posted

Median

Full Range

months

Up to approximately 9.49 months

ID	Title	Description
OG000	33A + HMA	33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
OG001	Placebo + HMA	placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks

Units	Counts

Secondary

Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events

Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. SAE = serious adverse event. "Study treatment" in this data set refers to blinded study treatment.

Safety analysis set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.

Posted

Count of Participants

Participants

Up to 1.5 years

ID	Title	Description
OG000	33A + HMA	33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
OG001	Placebo + HMA	placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks

Secondary

Incidence of Grade 3 or Higher Laboratory Abnormalities

Participants who experienced a laboratory grade increase to Grade 3 or higher (per National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI CTCAE], v4.03)

Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.

Posted

Count of Participants

Participants

Up to 1.5 years

ID	Title	Description
OG000	33A + HMA	33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
OG001	Placebo + HMA	placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks

Units	Counts
Participants

Secondary

Time to Complete Remission

Time to CR or CRi is the time from randomization to the first documentation of CR/CRi

Intent-to-Treat Analysis Set - Patients who Achieved CR/CRi.

Posted

Median

Full Range

weeks

Up to 1.5 years

ID	Title	Description
OG000	33A + HMA	33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
OG001	Placebo + HMA	placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks

Units	Counts
Participants	OG000

Secondary

Mortality Rates at Day 30 and Day 60

30- and 60-day survival from date of randomization. Estimated using Kaplan-Meier method.

Intent-to-Treat Analysis Set

Posted

Number

95% Confidence Interval

percentage of participants

Up to 60 days

ID	Title	Description
OG000	33A + HMA	33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks
OG001	Placebo + HMA	placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	33A + HMA	33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	43	111	92	111	105	111
EG001	Placebo + HMA	placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	34	128	89	128	123	128

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG00024 events22 affected111 at risk EG00116 events15 affected128 at risk
Sepsis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG00015 events14 affected111 at risk EG00110 events7 affected128 at risk
Cellulitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0006 events6 affected111 at risk EG0018 events8 affected128 at risk
Lung infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG00010 events9 affected111 at risk EG0013 events3 affected128 at risk
Septic shock	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0006 events6 affected111 at risk EG0011 events1 affected128 at risk
Urinary tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected111 at risk EG0014 events4 affected128 at risk
Diverticulitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected111 at risk EG0013 events3 affected128 at risk
Bronchitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0013 events3 affected128 at risk
Bacteraemia	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected111 at risk EG0011 events1 affected128 at risk
Klebsiella sepsis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected111 at risk EG0010 events0 affected128 at risk
Staphylococcal infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected111 at risk EG0011 events1 affected128 at risk
Abdominal infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected128 at risk
Device related infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected111 at risk EG0010 events0 affected128 at risk
Infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected111 at risk EG0010 events0 affected128 at risk
Influenza	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected128 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected128 at risk
Neutropenic sepsis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected128 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected111 at risk EG0010 events0 affected128 at risk
Streptococcal sepsis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected111 at risk EG0010 events0 affected128 at risk
Acinetobacter bacteraemia	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Anal abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Catheter site cellulitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Clostridium difficile infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Diarrhoea infectious	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Enterobacter bacteraemia	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Enterococcal infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Enterococcal sepsis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Escherichia sepsis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Necrotising fasciitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Parotitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Pharyngitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Pilonidal cyst	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Pneumonia fungal	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Pneumonia influenzal	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Postoperative wound infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Pseudomonas infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Sialoadenitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Sinusitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Skin infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Soft tissue infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events1 affected111 at risk EG0010 events0 affected128 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Tonsillitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Tooth abscess	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG00055 events39 affected111 at risk EG00139 events31 affected128 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0007 events6 affected111 at risk EG0012 events2 affected128 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0006 events5 affected111 at risk EG0012 events2 affected128 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0006 events5 affected111 at risk EG0010 events0 affected128 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected111 at risk EG0010 events0 affected128 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events2 affected111 at risk EG0011 events1 affected128 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected111 at risk EG0010 events0 affected128 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Pyrexia	General disorders	MedDRA (19.0)	Systematic Assessment	EG0008 events8 affected111 at risk EG0018 events8 affected128 at risk
General physical health deterioration	General disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0012 events2 affected128 at risk
Fatigue	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0012 events2 affected128 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0012 events2 affected128 at risk
Oedema peripheral	General disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected111 at risk EG0010 events0 affected128 at risk
Catheter site haemorrhage	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Chest pain	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Extravasation	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Facial pain	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Mucosal inflammation	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Sudden death	General disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected111 at risk EG0014 events3 affected128 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected111 at risk EG0011 events1 affected128 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected111 at risk EG0011 events1 affected128 at risk
Constipation	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected128 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0012 events2 affected128 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Anal fistula	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Melaena	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Oesophageal obstruction	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Palatal oedema	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Proctitis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Vomiting	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected111 at risk EG0015 events2 affected128 at risk
Cardiac failure	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected111 at risk EG0012 events2 affected128 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0012 events2 affected128 at risk
Cardiac arrest	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected128 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Angina unstable	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Atrial flutter	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Myocardial infarction	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Myocarditis	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Pericardial effusion	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected111 at risk EG0012 events2 affected128 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected111 at risk EG0010 events0 affected128 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0012 events2 affected128 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0012 events1 affected128 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Hypotension	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0012 events2 affected128 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected128 at risk
Embolism	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected111 at risk EG0010 events0 affected128 at risk
Haematoma	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected128 at risk
Haemorrhage	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Hypertension	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Thrombophlebitis	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected128 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0012 events2 affected128 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Blood culture positive	Investigations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected128 at risk
Ejection fraction decreased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected128 at risk
Alanine aminotransferase increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Blood creatinine increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
C-reactive protein increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
General physical condition abnormal	Investigations	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0014 events4 affected128 at risk
Urinary retention	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected128 at risk
Renal failure	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Urinary tract pain	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Seizure	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0011 events1 affected128 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Facial paresis	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Serotonin syndrome	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Somnolence	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0013 events3 affected128 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected111 at risk EG0010 events0 affected128 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0012 events1 affected128 at risk
Radiation proctitis	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Skin injury	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Hepatitis cholestatic	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Confusional state	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Delirium	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Mental status changes	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0000 events0 affected111 at risk EG0011 events1 affected128 at risk
Vasculitic rash	Skin and subcutaneous tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk
Blood product transfusion dependent	Social circumstances	MedDRA (19.0)	Systematic Assessment	EG0001 events1 affected111 at risk EG0010 events0 affected128 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG00048 events39 affected111 at risk EG00164 events54 affected128 at risk
Nausea	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG00049 events37 affected111 at risk EG00156 events45 affected128 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG00047 events34 affected111 at risk EG00152 events34 affected128 at risk
Vomiting	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG00025 events15 affected111 at risk EG00141 events31 affected128 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG00013 events11 affected111 at risk EG00115 events12 affected128 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0007 events7 affected111 at risk EG0019 events9 affected128 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG00010 events8 affected111 at risk EG0017 events6 affected128 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG00010 events10 affected111 at risk EG0011 events1 affected128 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (19.0)	Systematic Assessment	EG0005 events4 affected111 at risk EG0017 events7 affected128 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG00078 events49 affected111 at risk EG001105 events59 affected128 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG00073 events39 affected111 at risk EG00167 events47 affected128 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG00035 events19 affected111 at risk EG00134 events24 affected128 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG00029 events25 affected111 at risk EG00118 events12 affected128 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (19.0)	Systematic Assessment	EG00023 events13 affected111 at risk EG0019 events8 affected128 at risk
Oedema peripheral	General disorders	MedDRA (19.0)	Systematic Assessment	EG00038 events33 affected111 at risk EG00128 events23 affected128 at risk
Fatigue	General disorders	MedDRA (19.0)	Systematic Assessment	EG00027 events25 affected111 at risk EG00125 events24 affected128 at risk
Pyrexia	General disorders	MedDRA (19.0)	Systematic Assessment	EG00038 events25 affected111 at risk EG00131 events18 affected128 at risk
Asthenia	General disorders	MedDRA (19.0)	Systematic Assessment	EG00016 events13 affected111 at risk EG00114 events14 affected128 at risk
Injection site erythema	General disorders	MedDRA (19.0)	Systematic Assessment	EG00018 events11 affected111 at risk EG0016 events4 affected128 at risk
Chills	General disorders	MedDRA (19.0)	Systematic Assessment	EG0009 events8 affected111 at risk EG0015 events4 affected128 at risk
Localised oedema	General disorders	MedDRA (19.0)	Systematic Assessment	EG00011 events6 affected111 at risk EG0010 events0 affected128 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG00043 events28 affected111 at risk EG00136 events30 affected128 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG00036 events29 affected111 at risk EG00129 events28 affected128 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG00017 events11 affected111 at risk EG00116 events13 affected128 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG00012 events10 affected111 at risk EG00122 events13 affected128 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG00010 events9 affected111 at risk EG00110 events10 affected128 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG00011 events10 affected111 at risk EG0018 events8 affected128 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG00010 events8 affected111 at risk EG0019 events9 affected128 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (19.0)	Systematic Assessment	EG0003 events3 affected111 at risk EG0018 events7 affected128 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG00020 events17 affected111 at risk EG00131 events28 affected128 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG00022 events20 affected111 at risk EG00125 events20 affected128 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG00032 events21 affected111 at risk EG00112 events11 affected128 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG00015 events12 affected111 at risk EG0015 events5 affected128 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0007 events6 affected111 at risk EG0016 events6 affected128 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0006 events6 affected111 at risk EG0015 events4 affected128 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Systematic Assessment	EG0007 events7 affected111 at risk EG0013 events3 affected128 at risk
Weight decreased	Investigations	MedDRA (19.0)	Systematic Assessment	EG00017 events15 affected111 at risk EG00117 events17 affected128 at risk
Platelet count decreased	Investigations	MedDRA (19.0)	Systematic Assessment	EG00019 events12 affected111 at risk EG00112 events10 affected128 at risk
Blood creatinine increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG00010 events9 affected111 at risk EG0019 events7 affected128 at risk
Neutrophil count decreased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0008 events6 affected111 at risk EG00113 events8 affected128 at risk
White blood cell count decreased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0008 events6 affected111 at risk EG00110 events5 affected128 at risk
Blood bilirubin increased	Investigations	MedDRA (19.0)	Systematic Assessment	EG0006 events6 affected111 at risk EG0011 events1 affected128 at risk
Cellulitis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG00011 events10 affected111 at risk EG00110 events10 affected128 at risk
Oral candidiasis	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0007 events6 affected111 at risk EG00110 events9 affected128 at risk
Pneumonia	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG00011 events10 affected111 at risk EG0013 events3 affected128 at risk
Oral herpes	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0002 events2 affected111 at risk EG00112 events10 affected128 at risk
Urinary tract infection	Infections and infestations	MedDRA (19.0)	Systematic Assessment	EG0004 events4 affected111 at risk EG0019 events8 affected128 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (19.0)	Systematic Assessment	EG00015 events11 affected111 at risk EG00119 events15 affected128 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0008 events7 affected111 at risk EG00113 events13 affected128 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0004 events3 affected111 at risk EG00110 events8 affected128 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0006 events6 affected111 at risk EG0012 events2 affected128 at risk
Insomnia	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG00022 events21 affected111 at risk EG00113 events12 affected128 at risk
Confusional state	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0009 events7 affected111 at risk EG0017 events7 affected128 at risk
Anxiety	Psychiatric disorders	MedDRA (19.0)	Systematic Assessment	EG0008 events8 affected111 at risk EG0014 events4 affected128 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG00010 events10 affected111 at risk EG00112 events10 affected128 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0005 events5 affected111 at risk EG00110 events9 affected128 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG00012 events7 affected111 at risk EG0016 events6 affected128 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Systematic Assessment	EG0006 events6 affected111 at risk EG0013 events3 affected128 at risk
Hypotension	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG00012 events12 affected111 at risk EG00111 events9 affected128 at risk
Haematoma	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG00011 events9 affected111 at risk EG00112 events9 affected128 at risk
Hypertension	Vascular disorders	MedDRA (19.0)	Systematic Assessment	EG0007 events7 affected111 at risk EG0013 events3 affected128 at risk
Dizziness	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0006 events6 affected111 at risk EG00118 events17 affected128 at risk
Headache	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0007 events5 affected111 at risk EG00118 events17 affected128 at risk
Dysgeusia	Nervous system disorders	MedDRA (19.0)	Systematic Assessment	EG0007 events7 affected111 at risk EG0015 events5 affected128 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG00014 events11 affected111 at risk EG00111 events7 affected128 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (19.0)	Systematic Assessment	EG00013 events10 affected111 at risk EG0015 events5 affected128 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0008 events8 affected111 at risk EG0013 events3 affected128 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (19.0)	Systematic Assessment	EG0007 events7 affected111 at risk EG0013 events3 affected128 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0006 events6 affected111 at risk EG0018 events6 affected128 at risk
Urinary retention	Renal and urinary disorders	MedDRA (19.0)	Systematic Assessment	EG0006 events6 affected111 at risk EG0012 events2 affected128 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (19.0)	Systematic Assessment	EG0008 events6 affected111 at risk EG0013 events2 affected128 at risk

Ancestor Terms

ID	Term
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012263	Ribonucleosides

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
C000631166	vadastuximab talirine
D001374	Azacitidine
D000077209	Decitabine