A Study Evaluating Safety and Efficacy of Venetoclax in C... | NCT04161885

NCT04161885

ID	Type	Description	Link
2023-507222-17-00	Other Identifier	EU CT

Status 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
Part 1: Venetoclax + Azacitidine (AZA) + Best Supportive Care	Experimental	Participants will be administered various doses and dose regiments of venetoclax and AZA. Venetoclax will be administered once daily (QD) (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and best supportive care (BSC) for 24 cycles (each cycle = 28 days)	Drug: Venetoclax Drug: Azacitidine Other: Best Supportive Care (BSC)
Part 2: Arm B - Best Supportive Care (BSC)	Experimental	Participants will receive treatment as prescribed by their physician according to the BSC for up to 24 cycles (1 cycle = 28 days)	Other: Best Supportive Care (BSC)
Part 2: Arm A - Venetoclax + Azacitidine (AZA) + BSC	Experimental	Participants will be administered with venetoclax and AZA at a dose level determined in Part 1 in addition to best supportive care (when required). Venetoclax will be administered once daily (QD) (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and best supportive care (BSC) for 24 cycles (each cycle = 28 days).	Drug: Venetoclax Drug: Azacitidine Other: Best Supportive Care (BSC)

Name	Type	Description	Arm Group Labels	Other Names
Venetoclax	Drug	Tablet; Oral	Part 1: Venetoclax + Azacitidine (AZA) + Best Supportive Care Part 2: Arm A - Venetoclax + Azacitidine (AZA) + BSC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1)	DLTs were any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax and AZA as described in the protocol and evaluated by the Investigator and the sponsor.	Up to 28 days
Overall Survival (OS) (Part 2)	OS was defined as the time from the date of randomization to the date of death from any cause.	Up to approximately 41 months

Secondary Outcomes

Measure	Description	Time Frame
Morphologic Relapse-Free Survival (RFS) (Part 2)	Morphologic relapse from AML was defined as bone marrow blasts of >= 5% or reappearance of blasts in the peripheral blood not attributable to any other cause (e.g., bone marrow regeneration) in at least 2 peripheral blood samples at least one week apart or development of extramedullary disease after achieving a complete remission (CR) or complete remission with incomplete count recovery (CRi); or the date of death from any cause, whichever comes first as determined by the investigator.

Eligibility Module

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Oncology - Scottsdale - Cancer Transplant Institute /ID# 239711		Scottsdale	Arizona	85258-4547	United States

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part 1: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD	Participants were administered venetoclax and azacitidine (AZA). Venetoclax was administered once daily (QD) (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and best supportive care (BSC) for 24 cycles (each cycle = 28 days).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 8, 2025	Mar 31, 2026

Arm/Group Information

ID	Title	Description
BG000	Part 1: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD	Participants were administered venetoclax and AZA. Venetoclax was administered QD (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).
BG001	Part 1: Venetoclax 200 mg QD 14 Days + Azacitidine 20 mg/m^2 QD	Participants were administered venetoclax and AZA. Venetoclax was administered QD (Days 1-14) for up to 24 cycles, AZA QD on Days 1-5 of each 14-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).
BG002	Part 2: Best Supportive Care	Participants received treatment as prescribed by their physician according to the BSC for up to 24 cycles (each cycle = 28 days).
BG003	Part 2: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD	Participants received venetoclax and AZA in addition to best supportive care. Venetoclax was administered QD (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).
BG004	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, Customized

Count of Participants

Participants

Title

Denominators

Categories

< 18

Title	Measurements
	BG0000 BG0010 BG0023 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00011 BG0013 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

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

Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1)

DLTs were any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax and AZA as described in the protocol and evaluated by the Investigator and the sponsor.

The Safety Analysis Set included all participants who received at least one dose of study drug in Part 1. Here, "Overall number of participants analyzed" = number of participants evaluable for this outcome measure.

Posted

Count of Participants

Participants

Up to 28 days

ID	Title	Description
OG000	Part 1: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD	Participants were administered venetoclax and AZA. Venetoclax was administered QD (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).
OG001	Part 1: Venetoclax 200 mg QD 14 Days + Azacitidine 20 mg/m^2 QD	Participants were administered venetoclax and AZA. Venetoclax was administered QD (Days 1-14) for up to 24 cycles, AZA QD on Days 1-5 of each 14-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).

Units	Counts
Participants	OG00013 OG0014

Title

Denominators

Categories

Title	Measurements
	OG0003 OG0010

Primary

Overall Survival (OS) (Part 2)

OS was defined as the time from the date of randomization to the date of death from any cause.

The Intent-to-treat population included all randomized participants in Part 2.

Posted

Median

95% Confidence Interval

months

Up to approximately 41 months

ID	Title	Description
OG000	Part 2: Best Supportive Care	Participants received treatment as prescribed by their physician according to the BSC for up to 24 cycles (each cycle = 28 days).
OG001	Part 2: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD	Participants received venetoclax and AZA in addition to best supportive care. Venetoclax was administered QD (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).

Units	Counts
Participants	OG000

Secondary

Morphologic Relapse-Free Survival (RFS) (Part 2)

Morphologic relapse from AML was defined as bone marrow blasts of >= 5% or reappearance of blasts in the peripheral blood not attributable to any other cause (e.g., bone marrow regeneration) in at least 2 peripheral blood samples at least one week apart or development of extramedullary disease after achieving a complete remission (CR) or complete remission with incomplete count recovery (CRi); or the date of death from any cause, whichever comes first as determined by the investigator.

The Intent-to-treat Population included all randomized participants in Part 2.

Posted

Median

95% Confidence Interval

months

Up to approximately 41 months

ID	Title	Description
OG000	Part 2: Best Supportive Care	Participants received treatment as prescribed by their physician according to the BSC for up to 24 cycles (each cycle = 28 days).
OG001	Part 2: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD	Participants received venetoclax and AZA in addition to best supportive care. Venetoclax was administered QD (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).

Secondary

Composite Relapse-Free Survival (RFS) (Part 2)

Composite RFS was defined as the time from randomization from either morphologic relapse from AML, or non-morphologic relapse from AML, whichever comes first. Non-morphologic relapse from AML was defined as increase in disease burden determined by standard methods with reappearance or acquisition of new findings with or without change in anti-leukemic treatment per investigator decision due to cytogenetic abnormalities or change in molecular marker or measurable residual disease by multiparameter flow with sensitivity to at least 10^-3; or the date of death from any cause, whichever came first as determined by the investigator.

The Intent-to-treat Population included all randomized participants in Part 2.

Posted

Median

95% Confidence Interval

months

Up to approximately 41 months

ID	Title	Description
OG000	Part 2: Best Supportive Care	Participants received treatment as prescribed by their physician according to the BSC for up to 24 cycles (each cycle = 28 days).
OG001	Part 2: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD	Participants received venetoclax and AZA in addition to best supportive care. Venetoclax was administered QD (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).

Secondary

Graft-versus-Host Disease (GvHD)-Free, Relapse Free Survival (GRFS) (Part 2)

GRFS was defined as the time from the date of randomization to occurrence of disease relapse or incidence of GvHD or death from any cause.

The Intent-to-treat Population included all randomized participants in Part 2.

Posted

Median

95% Confidence Interval

months

Up to approximately 41 months

ID	Title	Description
OG000	Part 2: Best Supportive Care	Participants received treatment as prescribed by their physician according to the BSC for up to 24 cycles (each cycle = 28 days).
OG001	Part 2: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD	Participants received venetoclax and AZA in addition to best supportive care. Venetoclax was administered QD (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).

Units	Counts
Participants	OG000

Secondary

Rate of Participants Without Higher Grade of GvHD (Part 2)

Rate of Participants without higher grade of GvHD was defined as the percentage of participants without grade 2 or higher for acute graft-versus-host disease (aGvHD) and moderate/severe for chronic graft-versus-host disease (cGvHD) assessed by investigator at 90 days after randomization.

The Intent-to-treat Population included all randomized participants in Part 2.

Posted

Number

95% Confidence Interval

percentage of participants

90 days after randomization

ID	Title	Description
OG000	Part 2: Best Supportive Care	Participants received treatment as prescribed by their physician according to the BSC for up to 24 cycles (each cycle = 28 days).
OG001	Part 2: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD	Participants received venetoclax and AZA in addition to best supportive care. Venetoclax was administered QD (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).

Units	Counts
Participants

Secondary

Change From Baseline in Physical Functioning Subscore as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) (Part 2)

The EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales. The physical functioning score, reported here, ranged from 0 to 100, with a higher score indicating a better level of functioning. Positive changes from baseline indicate improvement.

The Intent-to-treat Population included all randomized participants in Part 2. Here, "Overall number of participants analyzed" = number of participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Month 6

ID	Title	Description
OG000	Part 2: Best Supportive Care	Participants received treatment as prescribed by their physician according to the BSC for up to 24 cycles (each cycle = 28 days).
OG001	Part 2: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD	Participants received venetoclax and AZA in addition to best supportive care. Venetoclax was administered QD (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).

Secondary

Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue Short Form (SF) 7a Score (Part 2)

PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much. The total raw score is the sum of the responses to each question and is converted to a T-score. The T-score re-scales the total raw score to a standardized score with a mean of 50 and a standard deviation of 10. T-Scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Negative changes from baseline indicate improvement.

The Intent-to-treat Population included all randomized participants in Part 2. Here, "Overall number of participants analyzed" = number of participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Month 6

ID	Title	Description
OG000	Part 2: Best Supportive Care	Participants received treatment as prescribed by their physician according to the BSC for up to 24 cycles (each cycle = 28 days).
OG001	Part 2: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD	Participants received venetoclax and AZA in addition to best supportive care. Venetoclax was administered QD (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).

Secondary

Percentage of Participants With Measurable Residual Disease (MRD) Conversion in Participants With MRD >= 10^-3 at Baseline (Part 2)

MRD conversion rate was defined as the percentage of participants who convert to MRD < 10^-3 after initiation of treatment. The population for MRD analysis included participants whose bone marrow was MRD positive (>=10^-3, as determined by central flow cytometry) at baseline prior to randomization.

The Intent-to-treat Population included all randomized participants in Part 2. Here, "Overall number of participants analyzed" = number of participants evaluable for this outcome measure.

Posted

Number

95% Confidence Interval

percentage of participants

Up to approximately 41 months

ID	Title	Description
OG000	Part 2: Best Supportive Care	Participants received treatment as prescribed by their physician according to the BSC for up to 24 cycles (each cycle = 28 days).
OG001	Part 2: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD	Participants received venetoclax and AZA in addition to best supportive care. Venetoclax was administered QD (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).

Secondary

Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) in Adult Participants (Part 2)

Time to deterioration was defined as number of days from randomization to either deterioration of >= 5 points based on the EORTC QLQ-C30 version 3 or death due to any cause. The GHS/QoL scale includes 2 questions in which participants were asked to rate their overall health and overall quality of life during the past week on a scale from 1 (very poor) to 7 (excellent). The 2 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL.

The Intent-to-treat Population included all randomized participants in Part 2. Here, "Overall number of participants analyzed" = number of participants evaluable for this outcome measure.

Posted

Median

95% Confidence Interval

months

Up to approximately 41 months

ID	Title	Description
OG000	Part 2: Best Supportive Care	Participants received treatment as prescribed by their physician according to the BSC for up to 24 cycles (each cycle = 28 days).
OG001	Part 2: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD	Participants received venetoclax and AZA in addition to best supportive care. Venetoclax was administered QD (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).

Secondary

Change From Baseline in European Quality-of-Life-5 Dimensional-5-Level (EQ-5D-5L) Score

The EQ-5D-5L is a generic preference instrument that has been validated in numerous populations and has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each of which are rated on five levels of severity (1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems) with higher scores representing higher symptom burden. A negative change from baseline indicates improvement in health status.

The Intent-to-treat Population included all randomized participants in Part 2. Here, "Overall number of participants analyzed" = number of participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Month 6

ID	Title	Description
OG000	Part 2: Best Supportive Care	Participants received treatment as prescribed by their physician according to the BSC for up to 24 cycles (each cycle = 28 days).
OG001	Part 2: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD	Participants received venetoclax and AZA in addition to best supportive care. Venetoclax was administered QD (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).

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	Part 1: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD	Participants were administered venetoclax and AZA. Venetoclax was administered QD (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).	12	30	9	30	30	30
EG001	Part 1: Venetoclax 200 mg QD 14 Days + Azacitidine 20 mg/m^2 QD	Participants were administered venetoclax and AZA. Venetoclax was administered QD (Days 1-14) for up to 24 cycles, AZA QD on Days 1-5 of each 14-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).	3	5	2	5	5	5
EG002	Part 2: Best Supportive Care	Participants received treatment as prescribed by their physician according to the BSC for up to 24 cycles (each cycle = 28 days).	46	216	66	216	179	216
EG003	Part 2: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD	Participants received venetoclax and AZA in addition to best supportive care. Venetoclax was administered QD (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and BSC for 24 cycles (each cycle = 28 days).	56	214	97	214	200	214

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG0031 events1 affected214 at risk
AUTOIMMUNE HAEMOLYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG0023 events3 affected216 at risk EG003
MYELOSUPPRESSION	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected5 at risk EG0020 events0 affected216 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected5 at risk EG0020 events0 affected216 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
CARDIAC ARREST	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
MYOCARDITIS	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
HYDROCELE	Congenital, familial and genetic disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
PHIMOSIS	Congenital, familial and genetic disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
BLINDNESS UNILATERAL	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
VISION BLURRED	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
COLITIS	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected5 at risk EG0022 events2 affected216 at risk EG003
DUODENAL ULCER	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
DYSPHAGIA	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
ENTEROCOLITIS	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
GASTROINTESTINAL INFLAMMATION	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
GASTROINTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
ILEUS	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
LARGE INTESTINE POLYP	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
ASTHENIA	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
CHEST DISCOMFORT	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
FATIGUE	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
INFLAMMATION	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
MASS	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
MULTIPLE ORGAN DYSFUNCTION SYNDROME	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
PYREXIA	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
CHOLANGITIS ACUTE	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
DRUG-INDUCED LIVER INJURY	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
HYPERBILIRUBINAEMIA	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
ACUTE GRAFT VERSUS HOST DISEASE IN INTESTINE	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
ACUTE GRAFT VERSUS HOST DISEASE IN SKIN	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
ANAPHYLACTIC REACTION	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
CHRONIC GRAFT VERSUS HOST DISEASE	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
CHRONIC GRAFT VERSUS HOST DISEASE IN INTESTINE	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
CHRONIC GRAFT VERSUS HOST DISEASE IN LUNG	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
GRAFT VERSUS HOST DISEASE	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0012 events1 affected5 at risk EG0021 events1 affected216 at risk EG003
GRAFT VERSUS HOST DISEASE IN EYE	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
GRAFT VERSUS HOST DISEASE IN GASTROINTESTINAL TRACT	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0023 events3 affected216 at risk EG003
GRAFT VERSUS HOST DISEASE IN LIVER	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
GRAFT VERSUS HOST DISEASE IN SKIN	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
ADENOVIRUS INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
APPENDICITIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
APPENDICITIS PERFORATED	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
ATYPICAL PNEUMONIA	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
BACTERAEMIA	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
BACTERIAL INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
BRONCHOPULMONARY ASPERGILLOSIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
CANDIDA INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
CELLULITIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
CLOSTRIDIUM COLITIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
CLOSTRIDIUM DIFFICILE INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
COVID-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0023 events3 affected216 at risk EG003
COVID-19 PNEUMONIA	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
CYSTITIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected5 at risk EG0020 events0 affected216 at risk EG003
CYTOMEGALOVIRUS CHORIORETINITIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
CYTOMEGALOVIRUS INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
CYTOMEGALOVIRUS INFECTION REACTIVATION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
CYTOMEGALOVIRUS VIRAEMIA	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
DEVICE RELATED SEPSIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
DIVERTICULITIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
ENCEPHALITIS FUNGAL	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
ENDOCARDITIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
ENTEROCOCCAL INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
EPSTEIN-BARR VIRAEMIA	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
EPSTEIN-BARR VIRUS INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
ESCHERICHIA BACTERAEMIA	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
ESCHERICHIA INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
GASTROENTERITIS ASTROVIRAL	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
HERPES SIMPLEX	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
HERPES ZOSTER	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0023 events3 affected216 at risk EG003
HERPES ZOSTER MENINGOENCEPHALITIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
INFLUENZA	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0022 events2 affected216 at risk EG003
INTERVERTEBRAL DISCITIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
NAIL INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
NEUTROPENIC SEPSIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
NOROVIRUS INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
PANTOEA AGGLOMERANS INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
PARAINFLUENZAE VIRUS INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0022 events2 affected216 at risk EG003
PERIRECTAL ABSCESS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
PNEUMOCYSTIS JIROVECII PNEUMONIA	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0022 events2 affected216 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected5 at risk EG00214 events12 affected216 at risk EG003
PNEUMONIA ASPIRATION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
PNEUMONIA CYTOMEGALOVIRAL	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
PNEUMONIA FUNGAL	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
PNEUMONIA INFLUENZAL	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
PNEUMONIA PNEUMOCOCCAL	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
PSEUDOMONAL SEPSIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
RASH PUSTULAR	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
RETINITIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
RHINOVIRUS INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
ROTAVIRUS INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
SEPSIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected30 at risk EG0010 events0 affected5 at risk EG00210 events8 affected216 at risk EG003
SEPTIC SHOCK	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
SINUSITIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
SINUSITIS BACTERIAL	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
SOFT TISSUE INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
STAPHYLOCOCCAL SEPSIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
STREPTOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
TOXOPLASMOSIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
VARICELLA	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
YERSINIA INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
FALL	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
PATELLA FRACTURE	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
STRESS FRACTURE	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
TRANSPLANT FAILURE	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
ULNAR NERVE INJURY	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
BLOOD CULTURE POSITIVE	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
CLOSTRIDIUM TEST POSITIVE	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
HEPATIC ENZYME INCREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
PLATELET COUNT DECREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0012 events1 affected5 at risk EG0020 events0 affected216 at risk EG003
WEIGHT DECREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
EATING DISORDER SYMPTOM	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0022 events2 affected216 at risk EG003
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0022 events1 affected216 at risk EG003
METABOLIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
INTERVERTEBRAL DISC DEGENERATION	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
OSTEONECROSIS	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
PATHOLOGICAL FRACTURE	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
SPINAL OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
ACUTE MYELOID LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
ACUTE MYELOID LEUKAEMIA RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
BLADDER NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
CENTRAL NERVOUS SYSTEM LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
COLORECTAL ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
COLORECTAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
LYMPHOPROLIFERATIVE DISORDER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
ALTERED STATE OF CONSCIOUSNESS	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
CENTRAL NERVOUS SYSTEM VASCULITIS	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
ENCEPHALITIS AUTOIMMUNE	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
GENERALISED TONIC-CLONIC SEIZURE	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
HEMIPARESIS	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
IIIRD NERVE PARALYSIS	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
ISCHAEMIC STROKE	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
REVERSIBLE CEREBRAL VASOCONSTRICTION SYNDROME	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
ADJUSTMENT DISORDER	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected5 at risk EG0020 events0 affected216 at risk EG003
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0023 events3 affected216 at risk EG003
CYSTITIS HAEMORRHAGIC	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
HAEMATURIA	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0012 events1 affected5 at risk EG0020 events0 affected216 at risk EG003
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
NEPHROTIC SYNDROME	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
BRONCHIOLITIS OBLITERANS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected5 at risk EG0020 events0 affected216 at risk EG003
IDIOPATHIC PNEUMONIA SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
LUNG INFILTRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
OBLITERATIVE BRONCHIOLITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
ORGANISING PNEUMONIA	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
RESPIRATORY DISTRESS	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0021 events1 affected216 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG00011 events8 affected30 at risk EG0012 events1 affected5 at risk EG00258 events33 affected216 at risk EG003106 events56 affected214 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG00013 events5 affected30 at risk EG0010 events0 affected5 at risk EG0022 events2 affected216 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG00047 events15 affected30 at risk EG0014 events2 affected5 at risk EG00255 events23 affected216 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG00020 events11 affected30 at risk EG0010 events0 affected5 at risk EG00225 events18 affected216 at risk EG003
ARRHYTHMIA	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
DRY EYE	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected30 at risk EG0010 events0 affected5 at risk EG00224 events21 affected216 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00010 events7 affected30 at risk EG0010 events0 affected5 at risk EG00211 events10 affected216 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0004 events2 affected30 at risk EG0010 events0 affected5 at risk EG0025 events5 affected216 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0007 events6 affected30 at risk EG0011 events1 affected5 at risk EG00214 events13 affected216 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00010 events9 affected30 at risk EG0011 events1 affected5 at risk EG00257 events37 affected216 at risk EG003
DRY MOUTH	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0011 events1 affected5 at risk EG00214 events13 affected216 at risk EG003
DYSPEPSIA	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected30 at risk EG0010 events0 affected5 at risk EG0024 events4 affected216 at risk EG003
FOOD POISONING	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
GASTRITIS	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected30 at risk EG0010 events0 affected5 at risk EG0024 events4 affected216 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00020 events14 affected30 at risk EG0012 events2 affected5 at risk EG00241 events28 affected216 at risk EG003
STOMATITIS	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0004 events2 affected30 at risk EG0010 events0 affected5 at risk EG00212 events9 affected216 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00010 events8 affected30 at risk EG0011 events1 affected5 at risk EG00232 events16 affected216 at risk EG003
ASTHENIA	General disorders	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected30 at risk EG0010 events0 affected5 at risk EG0025 events5 affected216 at risk EG003
CHEST PAIN	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected5 at risk EG0021 events1 affected216 at risk EG003
FATIGUE	General disorders	MedDRA 28.0	Systematic Assessment	EG00010 events8 affected30 at risk EG0010 events0 affected5 at risk EG00219 events16 affected216 at risk EG003
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected5 at risk EG0028 events6 affected216 at risk EG003
INJECTION SITE REACTION	General disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG00223 events20 affected216 at risk EG003
PYREXIA	General disorders	MedDRA 28.0	Systematic Assessment	EG0004 events3 affected30 at risk EG0010 events0 affected5 at risk EG00221 events17 affected216 at risk EG003
CHRONIC GRAFT VERSUS HOST DISEASE IN SKIN	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG00217 events13 affected216 at risk EG003
GRAFT VERSUS HOST DISEASE IN SKIN	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG00213 events12 affected216 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected5 at risk EG0026 events6 affected216 at risk EG003
CONJUNCTIVITIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG00217 events16 affected216 at risk EG003
COVID-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected30 at risk EG0011 events1 affected5 at risk EG00237 events36 affected216 at risk EG003
CYTOMEGALOVIRUS INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected5 at risk EG00212 events11 affected216 at risk EG003
CYTOMEGALOVIRUS INFECTION REACTIVATION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected30 at risk EG0010 events0 affected5 at risk EG00217 events14 affected216 at risk EG003
EPSTEIN-BARR VIRUS INFECTION REACTIVATION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected5 at risk EG0027 events6 affected216 at risk EG003
HEPATITIS C	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected5 at risk EG0020 events0 affected216 at risk EG003
HERPES ZOSTER	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected30 at risk EG0010 events0 affected5 at risk EG00216 events16 affected216 at risk EG003
INFLUENZA	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG0026 events6 affected216 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected30 at risk EG0010 events0 affected5 at risk EG00219 events15 affected216 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG00222 events18 affected216 at risk EG003
SEPSIS	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected5 at risk EG0020 events0 affected216 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected30 at risk EG0010 events0 affected5 at risk EG00273 events41 affected216 at risk EG003
VARICELLA ZOSTER VIRUS INFECTION	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected5 at risk EG0020 events0 affected216 at risk EG003
CONTUSION	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected5 at risk EG0025 events5 affected216 at risk EG003
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG0008 events6 affected30 at risk EG0013 events2 affected5 at risk EG00280 events39 affected216 at risk EG003
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG0008 events6 affected30 at risk EG0011 events1 affected5 at risk EG00247 events29 affected216 at risk EG003
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected30 at risk EG0010 events0 affected5 at risk EG00214 events9 affected216 at risk EG003
BLOOD BILIRUBIN INCREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0011 events1 affected5 at risk EG00210 events3 affected216 at risk EG003
BLOOD CREATININE INCREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG0007 events5 affected30 at risk EG0010 events0 affected5 at risk EG00213 events9 affected216 at risk EG003
BLOOD LACTATE DEHYDROGENASE INCREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG00215 events12 affected216 at risk EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG0006 events1 affected30 at risk EG0012 events1 affected5 at risk EG00222 events10 affected216 at risk EG003
LYMPHOCYTE COUNT DECREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected30 at risk EG0010 events0 affected5 at risk EG0022 events2 affected216 at risk EG003
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG00019 events6 affected30 at risk EG0010 events0 affected5 at risk EG00267 events25 affected216 at risk EG003
PLATELET COUNT DECREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG00016 events6 affected30 at risk EG0016 events1 affected5 at risk EG00248 events23 affected216 at risk EG003
WEIGHT DECREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected30 at risk EG0011 events1 affected5 at risk EG00210 events9 affected216 at risk EG003
WHITE BLOOD CELL COUNT DECREASED	Investigations	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected30 at risk EG0010 events0 affected5 at risk EG00230 events15 affected216 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected30 at risk EG0010 events0 affected5 at risk EG00215 events13 affected216 at risk EG003
FOLATE DEFICIENCY	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected5 at risk EG0020 events0 affected216 at risk EG003
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0004 events2 affected30 at risk EG0010 events0 affected5 at risk EG00211 events7 affected216 at risk EG003
HYPERLIPIDAEMIA	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected5 at risk EG0026 events6 affected216 at risk EG003
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG00230 events20 affected216 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG00237 events23 affected216 at risk EG003
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected5 at risk EG00221 events11 affected216 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0011 events1 affected5 at risk EG00234 events28 affected216 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG00216 events15 affected216 at risk EG003
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0004 events3 affected30 at risk EG0011 events1 affected5 at risk EG0026 events5 affected216 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG00212 events11 affected216 at risk EG003
POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected5 at risk EG0020 events0 affected216 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0026 events5 affected216 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected30 at risk EG0010 events0 affected5 at risk EG00222 events17 affected216 at risk EG003
ANXIETY	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected30 at risk EG0010 events0 affected5 at risk EG0025 events4 affected216 at risk EG003
INSOMNIA	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected5 at risk EG00214 events12 affected216 at risk EG003
URINARY RETENTION	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0011 events1 affected5 at risk EG0022 events1 affected216 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG00237 events33 affected216 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG00215 events14 affected216 at risk EG003
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected5 at risk EG0021 events1 affected216 at risk EG003
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected5 at risk EG0023 events3 affected216 at risk EG003
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected5 at risk EG0027 events4 affected216 at risk EG003
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected30 at risk EG0010 events0 affected5 at risk EG0029 events7 affected216 at risk EG003
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected30 at risk EG0011 events1 affected5 at risk EG0028 events6 affected216 at risk EG003
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0011 events1 affected5 at risk EG0024 events4 affected216 at risk EG003
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected5 at risk EG00222 events18 affected216 at risk EG003
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG0026 events5 affected216 at risk EG003
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0008 events5 affected30 at risk EG0010 events0 affected5 at risk EG00224 events21 affected216 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected30 at risk EG0011 events1 affected5 at risk EG00219 events17 affected216 at risk EG003
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected5 at risk EG00222 events20 affected216 at risk EG003
RASH PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected30 at risk EG0010 events0 affected5 at risk EG0020 events0 affected216 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected30 at risk EG0010 events0 affected5 at risk EG00215 events15 affected216 at risk EG003

Certain Agreements

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

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