SGI-110 in Adults With Untreated Acute Myeloid Leukemia (... | NCT02348489

NCT02348489

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SGI-110 (guadecitabine)	Experimental	Guadecitabine 60 mg/m^2 administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.	Drug: SGI-110 (guadecitabine)
Treatment Choice	Active Comparator	One of the following treatment regimens: 20 mg cytarabine administered subcutaneously (SC) twice daily (BID) on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.	Drug: Treatment Choice

Name	Type	Description	Arm Group Labels	Other Names
SGI-110 (guadecitabine)	Drug	Investigational medicinal product	SGI-110 (guadecitabine)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With a Complete Response (CR)	Number of participants with a best response of CR assessed based on International Working Group 2003 acute myeloid leukemia (AML) response criteria by a blinded independent pathologist.	Up to 38 months (median follow-up of 25.5 months)
Overall Survival	Survival time was defined as the number of days from the day the participant was randomly assigned to study treatment to the date of death, regardless of cause.	At 676 death events (up to 38 months)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Composite CR (CRc)	CRc is reported as the number of participants with a best response of CR, complete response with incomplete platelet recovery (CRp), or complete response with incomplete blood count recovery (CRi).	Up to 38 months (median follow-up of 25.5 months)
Number of Days Alive and Out of the Hospital

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) according to World Health Organization (WHO) classification.

Performance status (ECOG) of 0-3. Adults with previously untreated AML except for hydroxyurea or corticosteroids. Prior hydroxyurea or lenalidomide treatment for myelodysplastic syndrome (MDS) is allowed.

Not considered candidates for intensive remission induction chemotherapy at time of enrollment based on EITHER:

≥75 years of age OR
<75 years of age with at least 1 of the following:

i. Poor performance status (ECOG) score of 2-3.

ii. Clinically significant heart or lung comorbidities, as reflected by at least 1 of:

Left ventricular ejection fraction (LVEF) ≤50%.
Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected.
Forced expiratory volume in 1 second (FEV1) ≤65% of expected.
Chronic stable angina or congestive heart failure controlled with medication.

iii. Liver transaminases >3 × upper limit of normal (ULN).

iv. Other contraindication(s) to anthracycline therapy (must be documented).

v. Other comorbidity the investigator judges incompatible with intensive remission induction chemotherapy, which must be documented and approved by the study medical monitor before randomization.

Creatinine clearance as estimated by the Cockcroft-Gault (C-G) or other medically acceptable formulas ≥30 mL/min.

Exclusion Criteria:

Candidate for intensive remission induction chemotherapy at the time of enrollment.

Candidate for best supportive care only, ie, not a candidate for any active therapy with the TC comparators.

Known extramedullary central nervous system (CNS) AML.

Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy.

Prior treatment with decitabine or azacitidine.

Hypersensitivity to decitabine, SGI-110, or SGI-110 excipients.

Known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status or low viral hepatitis titer on antivirals is allowed.

Known significant mental illness or other condition such as active alcohol or other substance abuse or addiction that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol.

Refractory congestive heart failure unresponsive to medical treatment; active infection resistant to all antibiotics; or advanced pulmonary disease requiring >2 liters per minute (LPM) oxygen.

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Cancer Center		Scottsdale	Arizona	85259-5499	United States
Scripps Cancer Center

PubMed Identifier	Type	Citation	Retractions
37276510	Derived	Fenaux P, Gobbi M, Kropf PL, Issa JJ, Roboz GJ, Mayer J, Krauter J, Robak T, Kantarjian H, Novak J, Jedrzejczak WW, Thomas X, Ojeda-Uribe M, Miyazaki Y, Min YH, Yeh SP, Brandwein J, Gercheva-Kyuchukova L, Demeter J, Griffiths E, Yee K, Dohner K, Hao Y, Keer H, Azab M, Dohner H. Guadecitabine vs treatment choice in newly diagnosed acute myeloid leukemia: a global phase 3 randomized study. Blood Adv. 2023 Sep 12;7(17):5027-5037. doi: 10.1182/bloodadvances.2023010179.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	SGI-110 (Guadecitabine)	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
FG001	Treatment Choice	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) twice daily (BID) on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 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	Mar 6, 2015	Nov 11, 2020

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 a Complete Response (CR)

Number of participants with a best response of CR assessed based on International Working Group 2003 acute myeloid leukemia (AML) response criteria by a blinded independent pathologist.

The efficacy analysis set includes all randomized participants.

Posted

Count of Participants

Participants

Up to 38 months (median follow-up of 25.5 months)

ID	Title	Description
OG000	SGI-110 (Guadecitabine)	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
OG001	Treatment Choice	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.

Units	Counts
Participants	OG000408 OG001407

Title

Denominators

Categories

Title	Measurements
	OG00079 OG00171

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The complete response rate was compared between the treatment groups using a Cochran Mantel-Haenszel (CMH) test at an alpha level of 0.04 stratified to adjust for stratification factors used at randomization: age (<75 or >=75), Eastern Cooperative Oncology Group (ECOG) performance status (0-1, 2-3), study center region (North American, Europe, Rest of World), and secondary AML (secondary to MDS or other antecedent hematologic disorder) or poor-risk cytogenetics (Yes, No/Unknown).	Cochran-Mantel-Haenszel		0.482		Difference in response rate (%)	1.92			2-Sided	96	-3.67	7.5					Superiority

Primary

Overall Survival

Survival time was defined as the number of days from the day the participant was randomly assigned to study treatment to the date of death, regardless of cause.

The efficacy analysis set includes all randomized participants.

Posted

Median

95% Confidence Interval

days

At 676 death events (up to 38 months)

ID	Title	Description
OG000	SGI-110 (Guadecitabine)	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
OG001	Treatment Choice	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Composite CR (CRc)

CRc is reported as the number of participants with a best response of CR, complete response with incomplete platelet recovery (CRp), or complete response with incomplete blood count recovery (CRi).

The efficacy analysis set includes all randomized participants.

Posted

Count of Participants

Participants

Up to 38 months (median follow-up of 25.5 months)

ID	Title	Description
OG000	SGI-110 (Guadecitabine)	Guadecitabine 60 mg/m^2 was administered subcutaneously daily for 5 days (Days 1-5) in 28-day cycles.
OG001	Treatment Choice	One of the following treatment regimens were administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.

Units	Counts
Participants	OG000

Secondary

Number of Days Alive and Out of the Hospital

The date of each hospital admission and discharge was collected for each participant for up to 6 months, unless the participant died or withdrew consent prior to that time. Duration of each hospital stay in days was calculated as date of discharge minus date of admission. The Number of Days Alive and Out of the Hospital (NDAOH) was calculated as: NDAOH=180 - total duration of all hospital stays within 180 days from the first treatment - number of death days before Day 180. For subjects who were lost to follow-up within 6 months, the NDAOH was calculated conservatively assuming that the subject would have died the day after the last contact day.

The efficacy analysis set includes all randomized participants.

Posted

Mean

Standard Deviation

days

Month 6

ID	Title	Description
OG000	SGI-110 (Guadecitabine)	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
OG001	Treatment Choice	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.

Secondary

Progression-free Survival (PFS)

Progression-free survival was defined as the number of days from randomization to the earliest date of investigator's assessment of disease progression, participant receiving an alternative anti-leukemia therapy (including hematopoietic cell transplant), or relapse by peripheral blood (PB) assessment or blinded bone marrow (BM) assessment, whichever occurred first, or death, regardless of cause.

The efficacy analysis set includes all randomized participants.

Posted

Median

95% Confidence Interval

days

Up to 38 months (median follow-up of 25.5 months)

ID	Title	Description
OG000	SGI-110 (Guadecitabine)	Guadecitabine 60 mg/m^2 was administered subcutaneously daily for 5 days (Days 1-5) in 28-day cycles.
OG001	Treatment Choice	One of the following treatment regimens were administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.

Units	Counts
Participants

Secondary

Number of Red Blood Cell or Platelet Transfusions

The total number of red blood cells (RBCs) transfused or, separately, the total number of platelets transfused up to the 6-month time point for each participant was counted from the date of randomization to Day 180, the date of last contact, or date of death, whichever occurred earlier. One RBC or platelet transfusion was defined as one unit, and a single bag of RBCs or platelets was considered one unit.

The efficacy analysis set includes all randomized participants.

Posted

Mean

Standard Deviation

transfusion units

Month 6

ID	Title	Description
OG000	SGI-110 (Guadecitabine)	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
OG001	Treatment Choice	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.

Units	Counts
Participants

Secondary

Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-5D-5L

EuroQol 5-level 5-dimension (EQ-5D-5L) descriptive scores were collected for each participant for a minimum of 6 months, unless the participant died or withdrew consent. Scores within each dimension for EQ-5D (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) were calculated using counts and proportions. Mean change in scores from baseline are summarized in which an index score of 0 represents the worst health state and 1 represents the best health state.

The efficacy analysis set includes all randomized participants.

Posted

Mean

Standard Deviation

score on a scale

Baseline to Month 6

ID	Title	Description
OG000	SGI-110 (Guadecitabine)	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
OG001	Treatment Choice	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.

Units

Secondary

Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-VAS

EuroQol-Visual Analogue Scale (EQ-VAS) descriptive scores were collected for each participant for a minimum of 6 months, unless the participant died or withdrew consent. A vertical 20-cm scale for EQ-VAS was used where the lowest value of 0 was labeled "the worst health you can imagine" and the top value of 100 was labeled "the best health you can imagine." Mean change in scores from baseline are summarized.

The efficacy analysis set includes all randomized participants.

Posted

Mean

Standard Deviation

score on a scale

Baseline to Month 6

ID	Title	Description
OG000	SGI-110 (Guadecitabine)	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
OG001	Treatment Choice	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.

Units	Counts

Secondary

Duration of CR

Duration of CR (in number of days) was calculated from the first time a CR was observed to the time of relapse, defined as the earliest time point whereby BM assessment or PB assessment indicated relapse/disease progression due to reappearance of leukemic blasts in PB or ≥ 5% leukemic blasts in BM.

The efficacy analysis set includes all randomized participants.

Posted

Median

95% Confidence Interval

days

Up to 38 months (median follow-up of 25.5 months)

ID	Title	Description
OG000	SGI-110 (Guadecitabine)	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
OG001	Treatment Choice	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Anemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0010 events0 affected392 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected401 at risk EG0014 events4 affected392 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG000147 events101 affected401 at risk EG001138 events88 affected392 at risk
Hemorrhagic diathesis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected401 at risk EG0010 events0 affected392 at risk
Histiocytosis hematophagic	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0007 events6 affected401 at risk EG0012 events2 affected392 at risk
Lymphoadenopathy	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Lymphoadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Monoclonal B-cell lymphocytosis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0012 events2 affected392 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0011 events1 affected392 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0012 events2 affected392 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00015 events15 affected401 at risk EG0015 events5 affected392 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected401 at risk EG0010 events0 affected392 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0006 events3 affected401 at risk EG0013 events3 affected392 at risk
Angina pectoris	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected401 at risk EG0014 events4 affected392 at risk
Arrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected401 at risk EG00113 events6 affected392 at risk
Atrial flutter	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Cardiac arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected401 at risk EG0019 events9 affected392 at risk
Cardiac failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected401 at risk EG00111 events10 affected392 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0007 events4 affected401 at risk EG0013 events3 affected392 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0011 events1 affected392 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0013 events3 affected392 at risk
Pericardial effusion	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0012 events2 affected392 at risk
Pericarditis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Mastoid disorder	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Diabetes insipidus	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected401 at risk EG0012 events2 affected392 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0012 events2 affected392 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected401 at risk EG0011 events1 affected392 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected401 at risk EG0012 events2 affected392 at risk
Colitis ischemic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0012 events1 affected392 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0009 events8 affected401 at risk EG00110 events7 affected392 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Enteritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Fecaloma	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Gastric hemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected401 at risk EG0012 events1 affected392 at risk
Hemorrhoids	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Ileus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0010 events0 affected392 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0012 events2 affected392 at risk
Intussusception	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Melaena	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected401 at risk EG0012 events2 affected392 at risk
Mesenteric artery thrombosis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Esophagitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0010 events0 affected392 at risk
Pneumatosis intestinalis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Rectal hemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0014 events4 affected392 at risk
Small intestinal hemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected401 at risk EG0011 events1 affected392 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0012 events1 affected392 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0014 events4 affected392 at risk
Catheter site erythema	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Death	General disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected401 at risk EG0015 events5 affected392 at risk
Device related thrombosis	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Discomfort	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Gait disturbance	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0012 events2 affected392 at risk
General physical health deterioration	General disorders	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected401 at risk EG00110 events10 affected392 at risk
Impaired healing	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Injection site reaction	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Malaise	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected401 at risk EG0014 events4 affected392 at risk
Non-cardiac chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0010 events0 affected392 at risk
Edema peripheral	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG00019 events16 affected401 at risk EG00114 events13 affected392 at risk
Sudden cardiac death	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Sudden death	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0012 events2 affected392 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0012 events1 affected392 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Gallbladder obstruction	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Ischemic hepatitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected401 at risk EG0010 events0 affected392 at risk
Abscess intestinal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Anal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected401 at risk EG0011 events1 affected392 at risk
Appendicitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Arthritis bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Aspergillus infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected401 at risk EG0010 events0 affected392 at risk
Atypical pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0012 events2 affected392 at risk
Bacteremia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected401 at risk EG0012 events2 affected392 at risk
Bacterial infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0011 events1 affected392 at risk
Bacteroides bacteremia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected401 at risk EG0012 events2 affected392 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0012 events2 affected392 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected401 at risk EG0017 events6 affected392 at risk
Cellulitis orbital	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Clostridium colitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected401 at risk EG0010 events0 affected392 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected401 at risk EG0013 events2 affected392 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected401 at risk EG0012 events2 affected392 at risk
Cystitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected401 at risk EG0010 events0 affected392 at risk
Dermo-hypodermitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Device related infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected401 at risk EG0018 events7 affected392 at risk
Device related sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0012 events2 affected392 at risk
Diverticulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 events4 affected401 at risk EG0011 events1 affected392 at risk
Encephalomyelitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Endocarditis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Enterobacter infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Epiglottitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Erysipelas	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0012 events2 affected392 at risk
Escherichia bacteremia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0010 events0 affected392 at risk
Escherichia infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0012 events2 affected392 at risk
Eye infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Febrile infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Gastric infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0012 events2 affected392 at risk
Gastroenteritis pseudomonas	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Gingivitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
H1N1 influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Hematoma infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0010 events0 affected392 at risk
Hepatosplenic abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Herpes simplex	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Herpes zoster oticus	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected401 at risk EG0016 events5 affected392 at risk
Infectious colitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected401 at risk EG0013 events3 affected392 at risk
Injection site abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Injection site cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Injection site infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Kidney infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Klebsiella infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected401 at risk EG0010 events0 affected392 at risk
Liver abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Localized infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0011 events1 affected392 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Mastoiditis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Mucormycosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Muscle abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Neutropenic infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Osteomyelitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Otitis media	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Otitis media acute	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Parotitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected401 at risk EG0010 events0 affected392 at risk
Pathogen resistance	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Peritonitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Periumbilical abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Pharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0012 events1 affected392 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG000147 events117 affected401 at risk EG001102 events79 affected392 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Pneumonia legionella	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Post procedural cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Postoperative wound infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Pseudomonas infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0010 events0 affected392 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Pulpitis dental	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Pyelonephritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0012 events2 affected392 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Rectal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Scrotal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00083 events62 affected401 at risk EG00158 events44 affected392 at risk
Septic shock	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00017 events16 affected401 at risk EG00119 events17 affected392 at risk
Septic vasculitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0014 events4 affected392 at risk
Sinusitis fungal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Skin infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Soft tissue infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected401 at risk EG0012 events2 affected392 at risk
Staphylococcal bacteremia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Staphylococcal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0013 events3 affected392 at risk
Streptococcal bacteremia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Systemic candida	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Systemic infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Tonsillitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Tooth infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected401 at risk EG0011 events1 affected392 at risk
Tuberculous pleurisy	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected401 at risk EG0011 events1 affected392 at risk
Urethritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00016 events14 affected401 at risk EG00111 events10 affected392 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected401 at risk EG0010 events0 affected392 at risk
Urosepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected401 at risk EG0010 events0 affected392 at risk
Viral infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Wound infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0010 events0 affected392 at risk
Allergic transfusion reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected401 at risk EG0011 events1 affected392 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0012 events2 affected392 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0011 events1 affected392 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Hemolytic transfusion reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0012 events2 affected392 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Subarachnoid hemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Subdural hematoma	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0011 events1 affected392 at risk
Subdural hemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected401 at risk EG0010 events0 affected392 at risk
Traumatic lung injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0012 events1 affected392 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Blood bilirubin increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
C-reactive protein increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected401 at risk EG0013 events3 affected392 at risk
Influenza A virus test positive	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0010 events0 affected392 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0014 events4 affected392 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Hypercalcemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected401 at risk EG0010 events0 affected392 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0012 events2 affected392 at risk
Hypoglycemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0015 events4 affected392 at risk
Hyponatremia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0014 events3 affected392 at risk
Tumor lysis syndrome	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected401 at risk EG0012 events2 affected392 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0012 events2 affected392 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0010 events0 affected392 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Muscle atrophy	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Muscle hemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0012 events2 affected392 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0013 events2 affected392 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0012 events2 affected392 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Shoulder deformity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0012 events2 affected392 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0010 events0 affected392 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Biliary neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Central nervous system leukemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Chloroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Endometrial cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Kaposi's sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Tumor associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Cerebral hemorrhage	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0012 events2 affected392 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected401 at risk EG0012 events2 affected392 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Epilepsy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Facial paralysis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Hemorrhage intracranial	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0015 events4 affected392 at risk
Hemorrhagic stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Intracranial hematoma	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Ischemic stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0011 events1 affected392 at risk
Lethargy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Nervous system disorder	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Presyncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0012 events1 affected392 at risk
Seizure	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0012 events2 affected392 at risk
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0016 events4 affected392 at risk
Transient ischemic attack	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0012 events2 affected392 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Device dislocation	Product Issues	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Confusional state	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected401 at risk EG0010 events0 affected392 at risk
Delirium	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Personality change	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Suicide attempt	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG00011 events11 affected401 at risk EG00116 events15 affected392 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Cystitis hemorrhagic	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected401 at risk EG0010 events0 affected392 at risk
Hematuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0012 events2 affected392 at risk
Renal colic	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Renal failure	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected401 at risk EG0012 events2 affected392 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Urinary retention	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Acute pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0011 events1 affected392 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0010 events0 affected392 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0016 events6 affected392 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0012 events2 affected392 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected401 at risk EG0011 events1 affected392 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0012 events2 affected392 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected401 at risk EG0013 events3 affected392 at risk
Hemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Laryngeal edema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Organizing pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0011 events1 affected392 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 events6 affected401 at risk EG0013 events3 affected392 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected401 at risk EG0010 events0 affected392 at risk
Pulmonary alveolar hemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0010 events0 affected392 at risk
Pulmonary hemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected401 at risk EG0011 events1 affected392 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0011 events1 affected392 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected401 at risk EG0012 events2 affected392 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Acute febrile neutrophilic dermatosis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0010 events0 affected392 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Hypersensitivity vasculitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Pyoderma gangrenosum	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events1 affected401 at risk EG0010 events0 affected392 at risk
Rash generalized	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Aortic aneurysm	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Aortic dissection	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Artery dissection	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Circulatory collapse	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected401 at risk EG0014 events4 affected392 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0010 events0 affected392 at risk
Hematoma	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected401 at risk EG0012 events1 affected392 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0012 events2 affected392 at risk
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0013 events3 affected392 at risk
Iliac artery embolism	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Leriche syndrome	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Lupus vasculitis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Phlebitis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Shock	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0010 events0 affected392 at risk
Shock hemorrhagic	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Thrombophlebitis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected401 at risk EG0010 events0 affected392 at risk
Venous thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Bronchopulmonary aspergillosis allergic	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected401 at risk EG0011 events1 affected392 at risk
Urinary tract infection staphylococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected401 at risk EG0011 events1 affected392 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG000211 events88 affected401 at risk EG001201 events78 affected392 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG000103 events66 affected401 at risk EG00157 events40 affected392 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG000120 events37 affected401 at risk EG001124 events33 affected392 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG000319 events115 affected401 at risk EG001233 events88 affected392 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG000380 events116 affected401 at risk EG001313 events101 affected392 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00043 events30 affected401 at risk EG00150 events46 affected392 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00025 events21 affected401 at risk EG00116 events15 affected392 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG000166 events125 affected401 at risk EG001168 events114 affected392 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG000169 events122 affected401 at risk EG001116 events83 affected392 at risk
Hemorrhoids	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00028 events24 affected401 at risk EG00124 events19 affected392 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG000141 events91 affected401 at risk EG001150 events108 affected392 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00059 events46 affected401 at risk EG00144 events38 affected392 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00080 events58 affected401 at risk EG00182 events66 affected392 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG000102 events61 affected401 at risk EG00181 events55 affected392 at risk
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG00097 events63 affected401 at risk EG00174 events50 affected392 at risk
Injection site reaction	General disorders	MedDRA 21.0	Systematic Assessment	EG000148 events73 affected401 at risk EG00175 events48 affected392 at risk
Edema peripheral	General disorders	MedDRA 21.0	Systematic Assessment	EG000125 events95 affected401 at risk EG001108 events78 affected392 at risk
Pain	General disorders	MedDRA 21.0	Systematic Assessment	EG00022 events21 affected401 at risk EG00114 events14 affected392 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG000155 events89 affected401 at risk EG001176 events110 affected392 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00030 events22 affected401 at risk EG00115 events13 affected392 at risk
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00037 events29 affected401 at risk EG00125 events22 affected392 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00027 events18 affected401 at risk EG00121 events20 affected392 at risk
Oral candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00027 events23 affected401 at risk EG00121 events17 affected392 at risk
Oral herpes	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00036 events31 affected401 at risk EG00121 events20 affected392 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00064 events54 affected401 at risk EG00134 events31 affected392 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00034 events22 affected401 at risk EG00128 events20 affected392 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00046 events33 affected401 at risk EG00139 events28 affected392 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG00023 events20 affected401 at risk EG00127 events22 affected392 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG00043 events34 affected401 at risk EG00137 events29 affected392 at risk
Weight decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00047 events35 affected401 at risk EG00128 events25 affected392 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG000116 events89 affected401 at risk EG00180 events62 affected392 at risk
Hyperkalemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00033 events24 affected401 at risk EG00119 events13 affected392 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00036 events26 affected401 at risk EG00143 events23 affected392 at risk
Hypocalcemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00030 events25 affected401 at risk EG00129 events18 affected392 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG000173 events96 affected401 at risk EG001128 events77 affected392 at risk
Hypomagnesemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00050 events31 affected401 at risk EG00136 events27 affected392 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00028 events24 affected401 at risk EG00139 events35 affected392 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00043 events34 affected401 at risk EG00143 events36 affected392 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00020 events17 affected401 at risk EG00122 events20 affected392 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00051 events40 affected401 at risk EG00139 events32 affected392 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00047 events36 affected401 at risk EG00156 events42 affected392 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00044 events32 affected401 at risk EG00153 events38 affected392 at risk
Anxiety	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG00023 events23 affected401 at risk EG00124 events22 affected392 at risk
Depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG00015 events14 affected401 at risk EG00121 events21 affected392 at risk
Insomnia	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG00052 events38 affected401 at risk EG00156 events45 affected392 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG00024 events23 affected401 at risk EG00117 events16 affected392 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG000100 events79 affected401 at risk EG00183 events66 affected392 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00083 events63 affected401 at risk EG00160 events51 affected392 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00071 events53 affected401 at risk EG00151 events36 affected392 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00029 events22 affected401 at risk EG00127 events23 affected392 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00023 events21 affected401 at risk EG00113 events13 affected392 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00021 events21 affected401 at risk EG00120 events17 affected392 at risk
Pruritis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00028 events22 affected401 at risk EG00132 events26 affected392 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00055 events41 affected401 at risk EG00133 events28 affected392 at risk
Hematoma	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00033 events25 affected401 at risk EG00129 events19 affected392 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00042 events28 affected401 at risk EG00137 events25 affected392 at risk
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00040 events31 affected401 at risk EG00137 events31 affected392 at risk

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

ID	Title	Description
BG000	SGI-110 (Guadecitabine)	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
BG001	Treatment Choice	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SGI-110 (Guadecitabine)	Guadecitabine 60 mg/m^2 was administered subcutaneously daily for 5 days (Days 1-5) in 28-day cycles.	341	408	327	401	379	401
EG001	Treatment Choice	One of the following treatment regimens were administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.	344	407	297	392	371	392