Open-label Extension Study in Patients 65 Years or Older... | NCT01724346

NCT01724346

ID	Type	Description	Link
2012-003968-44	EudraCT Number

Status Module

Name	Class
Janssen Research & Development, LLC	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chlorambucil	Experimental	Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after disease progression (PD).	Drug: Ibrutinib
Ibrutinib	Experimental	Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.	Drug: Next-line ibrutinib

Name	Type	Description	Arm Group Labels	Other Names
Ibrutinib	Drug	Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily	Chlorambucil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS) Based on Investigator Assessment	PFS is defined as the time from the date of randomization to the date of disease progression determined by the investigator or date of death from any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to disease progression (PD) or death. Estimated by Kaplan-Meier method.	Median overall follow-up of 82.7 months

Secondary Outcomes

Measure	Description	Time Frame
Progression Free Survival After Initiation of Subsequent Anticancer Therapy (PFS2)	PFS2 is defined as the time from the date of randomization to the earliest occurrence of the following three types of events: PD per investigator response assessment after initiation of the first subsequent anti-cancer therapy Initiation of second subsequent anti-cancer therapy Death due to any cause, regardless of administration of subsequent anticancer therapy. Kaplan-Meier landmark estimate of the PFS2 rate at 60 months (that is, the estimated percentage of participants with PFS2 at Month 60) is presented.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope /ID# 1116-0047		Duarte	California	91010	United States
Moores Cancer Center at UC San Diego /ID# 1116-0408

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40737596	Derived	Burger JA, Barr PM, Robak T, Owen C, Tedeschi A, Sarma A, Patten PEM, Grosicki S, McCarthy H, Offner F, Szafer-Glusman E, Zhou C, Szoke A, Neumayr L, Dean JP, Ghia P, Kipps TJ. Final analysis of the RESONATE-2 study: up to 10 years of follow-up of first-line ibrutinib treatment for CLL/SLL. Blood. 2025 Oct 30;146(18):2168-2176. doi: 10.1182/blood.2024028205.
36617990

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ibrutinib	Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
FG001	Chlorambucil

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 10, 2022	Jul 17, 2024

Arm/Group Information

ID	Title	Description
BG000	Ibrutinib	Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
BG001	Chlorambucil	Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after PD.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00073.1± 5.67 BG00173.4± 5.95 BG00273.3± 5.81

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00048 BG00152 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0003 BG0012 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG000120 BG001125 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

Progression Free Survival (PFS) Based on Investigator Assessment

PFS is defined as the time from the date of randomization to the date of disease progression determined by the investigator or date of death from any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to disease progression (PD) or death. Estimated by Kaplan-Meier method.

Intent-to-Treat (ITT) Population: All randomized participants in Study 1115.

Posted

Median

95% Confidence Interval

months

Median overall follow-up of 82.7 months

ID	Title	Description
OG000	Ibrutinib	Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
OG001	Chlorambucil	Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after PD.

Units	Counts
Participants	OG000136 OG001133

Title

Denominators

Categories

Title	Measurements
	OG000106.9(83.4 to NA)Not estimable because there were not enough PFS events to get a reliable upper bound of 95% confidence interval (CI). OG00115.0(10.2 to 19.4)

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		Log Rank		< 0.0001	P-value is from stratified log-rank test.	Hazard Ratio (HR)	0.155			2-Sided	95	0.110	0.220					Superiority

Secondary

Progression Free Survival After Initiation of Subsequent Anticancer Therapy (PFS2)

PFS2 is defined as the time from the date of randomization to the earliest occurrence of the following three types of events:

PD per investigator response assessment after initiation of the first subsequent anti-cancer therapy
Initiation of second subsequent anti-cancer therapy
Death due to any cause, regardless of administration of subsequent anticancer therapy.

Kaplan-Meier landmark estimate of the PFS2 rate at 60 months (that is, the estimated percentage of participants with PFS2 at Month 60) is presented.

ITT Population: All randomized participants in Study 1115.

Posted

Number

95% Confidence Interval

percentage of participants

Median overall follow-up of 82.7 months

ID	Title	Description
OG000	Ibrutinib	Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
OG001	Chlorambucil	Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after PD.

Secondary

Overall Survival (OS)

OS is defined as the time from randomization to death due to any cause. Kaplan-Meier landmark estimate of the OS rate at 60 months (that is, the estimated percentage of participants with OS at Month 60) is presented.

ITT Population: All randomized participants in Study 1115.

Posted

Number

95% Confidence Interval

percentage of participants

Median overall follow-up of 82.7 months

ID	Title	Description
OG000	Ibrutinib	Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
OG001	Chlorambucil	Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after PD.

Units	Counts
Participants

Secondary

Time to Next Treatment (TTNT)

Time from randomization to initiation of any subsequent treatment for chronic lymphocytic leukemia (CLL).

ITT Population: All randomized participants in Study 1115.

Posted

Median

95% Confidence Interval

months

Median overall follow-up of 82.7 months

ID	Title	Description
OG000	Ibrutinib	Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
OG001	Chlorambucil	Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after PD.

Units	Counts
Participants	OG000

Secondary

Overall Response Rate (ORR)

ORR is defined as the percentage of participants who achieve complete response (CR), complete response with an incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR), as determined by the investigator at or prior to initiation of subsequent antineoplastic therapy according to the International Workshop on CLL (iwCLL) 2008 criteria with the 2012 iwCLL modification stating that treatment-related lymphocytosis in the setting of improvement in other parameters was not considered as PD and the 2013 iwCLL clarification of criteria for a partial response to therapy.

ITT Population: All randomized participants in Study 1115.

Posted

Number

percentage of participants

Median overall follow-up of 82.7 months

ID	Title	Description
OG000	Ibrutinib	Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
OG001	Chlorambucil	Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after PD.

Secondary

Rate of Minimal Residual Disease (MRD) Negativity

Percentage of participants who achieved MRD-negative response defined as < 1 CLL cell per 10,000 leukocytes as assessed by flow cytometry of a bone marrow aspirate and/or peripheral blood sample per central laboratory at or prior to initiation of subsequent antineoplastic therapy.

ITT Population: All randomized participants in Study 1115.

Posted

Number

percentage of participants

Median overall follow-up of 82.7 months

ID	Title	Description
OG000	Ibrutinib	Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
OG001	Chlorambucil	Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after PD.

Units	Counts
Participants

Secondary

Duration of Response (DOR)

DOR will be calculated for the participants achieving a protocol-defined response (Halleck 2008; CR, CRi, nPR, PR) per investigator assessment and is defined as time from the date of initial response including PR with lymphocytosis to the date of disease progression or the date of death from any cause, whichever occurs first.

ITT Participants Achieving Response (Partial Response or Better) per protocol definitions (Halleck 2008).

Posted

Median

95% Confidence Interval

months

Median overall follow-up of 82.7 months

ID	Title	Description
OG000	Ibrutinib	Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
OG001	Chlorambucil	Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after PD.

Units	Counts
Participants

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	Ibrutinib	Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.	42	135	111	135	134	135
EG001	Chlorambucil	Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115.	44	132	33	132	120	132
EG002	Next-line Ibrutinib After PD on Chlorambucil	Participants who received chlorambucil treatment in Study 1115 and crossed over to next-line ibrutinib 420 mg/day in Study 1116.	24	78	49	78	75	78

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected135 at risk EG0012 events2 affected132 at risk EG0021 events1 affected78 at risk
AUTOIMMUNE HAEMOLYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0005 events4 affected135 at risk EG0012 events2 affected132 at risk EG0022 events2 affected78 at risk
HAEMOLYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected135 at risk EG0012 events2 affected132 at risk EG0022 events2 affected78 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0011 events1 affected132 at risk EG0021 events1 affected78 at risk
AORTIC VALVE DISEASE	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
AORTIC VALVE DISEASE MIXED	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
ARRHYTHMIA	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG00011 events11 affected135 at risk EG0011 events1 affected132 at risk EG0028 events6 affected78 at risk
ATRIAL FLUTTER	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CARDIAC DYSFUNCTION	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0006 events5 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0012 events1 affected132 at risk EG0020 events0 affected78 at risk
CARDIAC TAMPONADE	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
CARDIOPULMONARY FAILURE	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
MITRAL VALVE INCOMPETENCE	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0013 events1 affected132 at risk EG0020 events0 affected78 at risk
PALPITATIONS	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
SINUS NODE DYSFUNCTION	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
THYROGLOSSAL CYST	Congenital, familial and genetic disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
BLINDNESS UNILATERAL	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CATARACT	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
EYE OEDEMA	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
GLAUCOMA	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
RETINAL DETACHMENT	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
RETINAL VASCULAR OCCLUSION	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
RETINAL VEIN OCCLUSION	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
VITREOUS HAEMORRHAGE	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0023 events3 affected78 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ABDOMINAL WALL HAEMATOMA	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
COLITIS	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected135 at risk EG0010 events0 affected132 at risk EG0022 events2 affected78 at risk
DIVERTICULUM	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0011 events1 affected132 at risk EG0021 events1 affected78 at risk
HIATUS HERNIA	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ILEUS PARALYTIC	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
MELAENA	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
OESOPHAGEAL STENOSIS	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
OVERFLOW DIARRHOEA	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0023 events2 affected78 at risk
VOMITING	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CHEST PAIN	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CHILLS	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
DEATH	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
FATIGUE	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
MULTIPLE ORGAN DYSFUNCTION SYNDROME	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
PAIN	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
PHYSICAL DECONDITIONING	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
PYREXIA	General disorders	MedDRA 26.0	Systematic Assessment	EG0006 events4 affected135 at risk EG0015 events5 affected132 at risk EG0022 events1 affected78 at risk
SUDDEN DEATH	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
BILE DUCT STONE	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
CHOLANGITIS	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0005 events3 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
HEPATITIS	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
HEPATITIS TOXIC	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
JAUNDICE CHOLESTATIC	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
HYPOGAMMAGLOBULINAEMIA	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
IMMUNODEFICIENCY	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ABSCESS LIMB	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ACUTE HEPATITIS B	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
ANAL ABSCESS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ARTHRITIS BACTERIAL	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
BACTERAEMIA	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
BACTERIAL SEPSIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
BILIARY SEPSIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
BRONCHITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
COVID-19 PNEUMONIA	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CAMPYLOBACTER GASTROENTERITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
CANDIDA SEPSIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
CELLULITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected135 at risk EG0010 events0 affected132 at risk EG0022 events2 affected78 at risk
CHOLANGITIS INFECTIVE	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CHRONIC SINUSITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CLOSTRIDIUM DIFFICILE INFECTION	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CORONAVIRUS INFECTION	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
EAR INFECTION	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
ENDOCARDITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
ERYSIPELAS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
ESCHERICHIA BACTERAEMIA	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ESCHERICHIA INFECTION	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ESCHERICHIA SEPSIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
INFECTED SKIN ULCER	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0022 events1 affected78 at risk
INFLUENZA	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
KLEBSIELLA INFECTION	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0005 events4 affected135 at risk EG0011 events1 affected132 at risk EG0023 events2 affected78 at risk
LOWER RESPIRATORY TRACT INFECTION VIRAL	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
NEUTROPENIC SEPSIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0011 events1 affected132 at risk EG0021 events1 affected78 at risk
ORAL HERPES	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
ORCHITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
OSTEOMYELITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
PNEUMOCOCCAL SEPSIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
PNEUMONIA	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00038 events27 affected135 at risk EG0012 events2 affected132 at risk EG00214 events7 affected78 at risk
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0011 events1 affected132 at risk EG0021 events1 affected78 at risk
PNEUMONIA FUNGAL	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
PNEUMONIA LEGIONELLA	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
PNEUMONIA PSEUDOMONAL	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
PNEUMONIA STREPTOCOCCAL	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
PNEUMONIA VIRAL	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
POST PROCEDURAL PNEUMONIA	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
PSEUDOMONAL BACTERAEMIA	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
PSEUDOMONAL SEPSIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
PULMONARY SEPSIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
PYELONEPHRITIS ACUTE	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
SEPSIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0006 events5 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
STAPHYLOCOCCAL SEPSIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
SUBCUTANEOUS ABSCESS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00011 events6 affected135 at risk EG0010 events0 affected132 at risk EG0025 events5 affected78 at risk
UROSEPSIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
VIRAL INFECTION	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
WOUND INFECTION	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ANIMAL BITE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ANKLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected135 at risk EG0010 events0 affected132 at risk EG0022 events2 affected78 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0011 events1 affected132 at risk EG0022 events2 affected78 at risk
FRACTURED SACRUM	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
HEAT STROKE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
HYPHAEMA	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
LIMB TRAUMATIC AMPUTATION	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
LOWER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
MUSCLE STRAIN	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
OVERDOSE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
PELVIC FRACTURE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
POST PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
POSTOPERATIVE WOUND COMPLICATION	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
RADIUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
SHOULDER FRACTURE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
SKIN LACERATION	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
SPINAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
SUBCUTANEOUS HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
SUBDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
TOXICITY TO VARIOUS AGENTS	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
TRAUMATIC HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ULNA FRACTURE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
URINARY RETENTION POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
FIBRIN D DIMER INCREASED	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
HEART RATE IRREGULAR	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
WEIGHT DECREASED	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
DIABETES MELLITUS INADEQUATE CONTROL	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
FAILURE TO THRIVE	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0007 events5 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0007 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
HYPOVOLAEMIA	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
HAEMATOMA MUSCLE	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
LUMBAR SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0022 events1 affected78 at risk
RHABDOMYOLYSIS	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
SPINAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ADENOCARCINOMA OF COLON	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG00012 events9 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
BASOSQUAMOUS CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
BLADDER CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
BLADDER TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
BOWEN'S DISEASE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
BRAIN NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0022 events1 affected78 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CHRONIC LYMPHOCYTIC LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
COLORECTAL ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
LUNG ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
LUNG NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0004 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
MUCINOUS ADENOCARCINOMA OF APPENDIX	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
NON-SMALL CELL LUNG CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
NON-SMALL CELL LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
RECTAL ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
RICHTER'S SYNDROME	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
SPINDLE CELL SARCOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0011 events1 affected132 at risk EG0025 events2 affected78 at risk
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0022 events1 affected78 at risk
CAUDA EQUINA SYNDROME	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CEREBELLAR INFARCTION	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CEREBRAL INFARCTION	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected135 at risk EG0010 events0 affected132 at risk EG0022 events2 affected78 at risk
COGNITIVE DISORDER	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
DEMENTIA	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
DEMENTIA ALZHEIMER'S TYPE	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
DYSARTHRIA	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
EPILEPSY	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
HEADACHE	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
HEMIANOPIA HOMONYMOUS	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
ISCHAEMIC STROKE	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
METABOLIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
POST HERPETIC NEURALGIA	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0012 events1 affected132 at risk EG0020 events0 affected78 at risk
PRESYNCOPE	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
SEIZURE	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
SUBARACHNOID HAEMORRHAGE	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
SYNCOPE	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0007 events5 affected135 at risk EG0012 events2 affected132 at risk EG0021 events1 affected78 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0006 events5 affected135 at risk EG0011 events1 affected132 at risk EG0022 events2 affected78 at risk
DEVICE OCCLUSION	Product Issues	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
CARDIOVASCULAR SOMATIC SYMPTOM DISORDER	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
DELIRIUM	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
PSYCHOTIC DISORDER	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0005 events4 affected135 at risk EG0010 events0 affected132 at risk EG0022 events1 affected78 at risk
BLADDER CYST	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
BLADDER TAMPONADE	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CALCULUS BLADDER	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CHRONIC KIDNEY DISEASE	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
CYSTITIS HAEMORRHAGIC	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
RENAL HAEMORRHAGE	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
URETEROLITHIASIS	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
PERINEAL FISTULA	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
BRONCHIECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
HYPERCAPNIA	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
LUNG INFILTRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0008 events5 affected135 at risk EG0014 events2 affected132 at risk EG0022 events2 affected78 at risk
PNEUMOMEDIASTINUM	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
PULMONARY ARTERIAL HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
PULMONARY CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
PULMONARY FIBROSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
WHEEZING	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
DERMAL CYST	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
DERMATITIS ALLERGIC	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ECZEMA	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
PSORIASIS	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
RASH MACULAR	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
SUBCUTANEOUS EMPHYSEMA	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
AORTIC ANEURYSM	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
AORTIC STENOSIS	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
HAEMATOMA	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
HYPERTENSION	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
HYPOTENSION	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
PERIPHERAL ARTERY ANEURYSM	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
PERIPHERAL ISCHAEMIA	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected135 at risk EG0010 events0 affected132 at risk EG0022 events1 affected78 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00086 events33 affected135 at risk EG00153 events25 affected132 at risk EG00229 events14 affected78 at risk
INCREASED TENDENCY TO BRUISE	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00029 events22 affected135 at risk EG0015 events5 affected132 at risk EG0028 events8 affected78 at risk
IRON DEFICIENCY ANAEMIA	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0009 events6 affected135 at risk EG0010 events0 affected132 at risk EG0024 events4 affected78 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00043 events24 affected135 at risk EG00150 events28 affected132 at risk EG00217 events7 affected78 at risk
SPONTANEOUS HAEMATOMA	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00013 events7 affected135 at risk EG0010 events0 affected132 at risk EG0024 events4 affected78 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00049 events20 affected135 at risk EG00129 events17 affected132 at risk EG0029 events8 affected78 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG00023 events21 affected135 at risk EG0010 events0 affected132 at risk EG0027 events6 affected78 at risk
PALPITATIONS	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG00013 events11 affected135 at risk EG0011 events1 affected132 at risk EG0026 events5 affected78 at risk
CATARACT	Eye disorders	MedDRA 26.0	Systematic Assessment	EG00027 events22 affected135 at risk EG0012 events2 affected132 at risk EG0027 events5 affected78 at risk
CONJUNCTIVAL HAEMORRHAGE	Eye disorders	MedDRA 26.0	Systematic Assessment	EG00014 events14 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
DRY EYE	Eye disorders	MedDRA 26.0	Systematic Assessment	EG00040 events27 affected135 at risk EG0017 events6 affected132 at risk EG0026 events5 affected78 at risk
EYE IRRITATION	Eye disorders	MedDRA 26.0	Systematic Assessment	EG00023 events13 affected135 at risk EG0015 events5 affected132 at risk EG0027 events4 affected78 at risk
EYE PAIN	Eye disorders	MedDRA 26.0	Systematic Assessment	EG00014 events10 affected135 at risk EG0012 events2 affected132 at risk EG0024 events3 affected78 at risk
LACRIMATION INCREASED	Eye disorders	MedDRA 26.0	Systematic Assessment	EG00047 events20 affected135 at risk EG00110 events8 affected132 at risk EG00210 events6 affected78 at risk
PHOTOPHOBIA	Eye disorders	MedDRA 26.0	Systematic Assessment	EG00010 events8 affected135 at risk EG0012 events2 affected132 at risk EG0028 events4 affected78 at risk
VISION BLURRED	Eye disorders	MedDRA 26.0	Systematic Assessment	EG00033 events23 affected135 at risk EG00111 events11 affected132 at risk EG00211 events8 affected78 at risk
VISUAL ACUITY REDUCED	Eye disorders	MedDRA 26.0	Systematic Assessment	EG00024 events17 affected135 at risk EG0013 events3 affected132 at risk EG0023 events3 affected78 at risk
VITREOUS FLOATERS	Eye disorders	MedDRA 26.0	Systematic Assessment	EG00019 events13 affected135 at risk EG0018 events7 affected132 at risk EG0024 events2 affected78 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00030 events22 affected135 at risk EG00113 events13 affected132 at risk EG0028 events6 affected78 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00013 events10 affected135 at risk EG0017 events6 affected132 at risk EG0026 events4 affected78 at risk
APHTHOUS ULCER	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0007 events7 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00048 events30 affected135 at risk EG00121 events21 affected132 at risk EG00214 events12 affected78 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG000145 events67 affected135 at risk EG00133 events22 affected132 at risk EG00260 events27 affected78 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00026 events21 affected135 at risk EG0013 events3 affected132 at risk EG00211 events11 affected78 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00017 events17 affected135 at risk EG0012 events2 affected132 at risk EG0023 events3 affected78 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0009 events8 affected135 at risk EG0013 events3 affected132 at risk EG0022 events2 affected78 at risk
MOUTH ULCERATION	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0009 events9 affected135 at risk EG0010 events0 affected132 at risk EG0022 events2 affected78 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00060 events43 affected135 at risk EG00175 events52 affected132 at risk EG00222 events13 affected78 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00022 events13 affected135 at risk EG0015 events5 affected132 at risk EG0023 events2 affected78 at risk
VOMITING	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00037 events29 affected135 at risk EG00142 events27 affected132 at risk EG00217 events10 affected78 at risk
ASTHENIA	General disorders	MedDRA 26.0	Systematic Assessment	EG00020 events17 affected135 at risk EG0017 events5 affected132 at risk EG00212 events9 affected78 at risk
CHEST PAIN	General disorders	MedDRA 26.0	Systematic Assessment	EG00011 events10 affected135 at risk EG0010 events0 affected132 at risk EG0026 events4 affected78 at risk
FATIGUE	General disorders	MedDRA 26.0	Systematic Assessment	EG000110 events55 affected135 at risk EG00185 events51 affected132 at risk EG00235 events18 affected78 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 26.0	Systematic Assessment	EG00071 events39 affected135 at risk EG00111 events11 affected132 at risk EG00221 events15 affected78 at risk
PAIN	General disorders	MedDRA 26.0	Systematic Assessment	EG0007 events7 affected135 at risk EG0010 events0 affected132 at risk EG0024 events3 affected78 at risk
PERIPHERAL SWELLING	General disorders	MedDRA 26.0	Systematic Assessment	EG00010 events7 affected135 at risk EG0012 events2 affected132 at risk EG0025 events4 affected78 at risk
PYREXIA	General disorders	MedDRA 26.0	Systematic Assessment	EG00059 events36 affected135 at risk EG00123 events14 affected132 at risk EG00220 events9 affected78 at risk
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG00024 events7 affected135 at risk EG0010 events0 affected132 at risk EG00211 events3 affected78 at risk
BRONCHITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00034 events17 affected135 at risk EG0015 events4 affected132 at risk EG0027 events5 affected78 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00018 events15 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
CELLULITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00017 events13 affected135 at risk EG0011 events1 affected132 at risk EG0023 events3 affected78 at risk
CONJUNCTIVITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00037 events22 affected135 at risk EG0013 events3 affected132 at risk EG00211 events8 affected78 at risk
CYSTITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00011 events7 affected135 at risk EG0010 events0 affected132 at risk EG0022 events1 affected78 at risk
EYE INFECTION	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0009 events8 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
FOLLICULITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0007 events7 affected135 at risk EG0010 events0 affected132 at risk EG0020 events0 affected78 at risk
HERPES ZOSTER	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00014 events13 affected135 at risk EG0018 events7 affected132 at risk EG0021 events1 affected78 at risk
INFLUENZA	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00011 events7 affected135 at risk EG0014 events4 affected132 at risk EG0029 events7 affected78 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00027 events15 affected135 at risk EG0016 events6 affected132 at risk EG00211 events5 affected78 at risk
PHARYNGITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0009 events8 affected135 at risk EG0010 events0 affected132 at risk EG0022 events2 affected78 at risk
PNEUMONIA	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00016 events12 affected135 at risk EG0013 events3 affected132 at risk EG0029 events5 affected78 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0008 events6 affected135 at risk EG0013 events2 affected132 at risk EG0029 events4 affected78 at risk
RHINITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00014 events7 affected135 at risk EG0012 events2 affected132 at risk EG0020 events0 affected78 at risk
SINUSITIS	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00014 events9 affected135 at risk EG0011 events1 affected132 at risk EG0023 events3 affected78 at risk
SKIN INFECTION	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00016 events13 affected135 at risk EG0013 events3 affected132 at risk EG0021 events1 affected78 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00073 events38 affected135 at risk EG00130 events23 affected132 at risk EG00231 events20 affected78 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00087 events29 affected135 at risk EG00115 events10 affected132 at risk EG00214 events10 affected78 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG00040 events26 affected135 at risk EG0012 events2 affected132 at risk EG0024 events4 affected78 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG00045 events25 affected135 at risk EG0015 events3 affected132 at risk EG00214 events9 affected78 at risk
PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0008 events8 affected135 at risk EG0011 events1 affected132 at risk EG0021 events1 affected78 at risk
SKIN ABRASION	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG00010 events9 affected135 at risk EG0011 events1 affected132 at risk EG0022 events1 affected78 at risk
SKIN LACERATION	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG00010 events5 affected135 at risk EG0015 events4 affected132 at risk EG0024 events4 affected78 at risk
TRAUMATIC HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0009 events6 affected135 at risk EG0012 events2 affected132 at risk EG0025 events4 affected78 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA 26.0	Systematic Assessment	EG00016 events11 affected135 at risk EG0013 events2 affected132 at risk EG0025 events5 affected78 at risk
PLATELET COUNT DECREASED	Investigations	MedDRA 26.0	Systematic Assessment	EG00062 events7 affected135 at risk EG00110 events6 affected132 at risk EG0026 events1 affected78 at risk
WEIGHT DECREASED	Investigations	MedDRA 26.0	Systematic Assessment	EG00047 events34 affected135 at risk EG00116 events16 affected132 at risk EG00216 events12 affected78 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00038 events24 affected135 at risk EG00126 events19 affected132 at risk EG00210 events7 affected78 at risk
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00037 events23 affected135 at risk EG0011 events1 affected132 at risk EG0025 events2 affected78 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00025 events7 affected135 at risk EG0013 events3 affected132 at risk EG0021 events1 affected78 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00026 events16 affected135 at risk EG0012 events2 affected132 at risk EG0029 events6 affected78 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00015 events7 affected135 at risk EG0011 events1 affected132 at risk EG00210 events5 affected78 at risk
IRON DEFICIENCY	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00014 events12 affected135 at risk EG0010 events0 affected132 at risk EG0025 events5 affected78 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00075 events41 affected135 at risk EG00118 events10 affected132 at risk EG00240 events22 affected78 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00038 events27 affected135 at risk EG0019 events9 affected132 at risk EG00212 events10 affected78 at risk
JOINT SWELLING	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0009 events7 affected135 at risk EG0011 events1 affected132 at risk EG0024 events3 affected78 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00040 events28 affected135 at risk EG0017 events7 affected132 at risk EG00220 events13 affected78 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00010 events9 affected135 at risk EG0012 events2 affected132 at risk EG0022 events2 affected78 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00017 events11 affected135 at risk EG0016 events4 affected132 at risk EG0023 events3 affected78 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00011 events8 affected135 at risk EG0015 events4 affected132 at risk EG0023 events2 affected78 at risk
OSTEOPOROSIS	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0008 events8 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00027 events23 affected135 at risk EG0017 events7 affected132 at risk EG00210 events8 affected78 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG00022 events14 affected135 at risk EG0013 events2 affected132 at risk EG0026 events5 affected78 at risk
SEBORRHOEIC KERATOSIS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0008 events7 affected135 at risk EG0010 events0 affected132 at risk EG0021 events1 affected78 at risk
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG00010 events8 affected135 at risk EG0012 events2 affected132 at risk EG0021 events1 affected78 at risk
DIZZINESS	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00029 events25 affected135 at risk EG00122 events16 affected132 at risk EG00214 events10 affected78 at risk
HEADACHE	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00032 events19 affected135 at risk EG00123 events13 affected132 at risk EG00217 events9 affected78 at risk
HYPOAESTHESIA	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00010 events7 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0008 events7 affected135 at risk EG0011 events1 affected132 at risk EG0026 events4 affected78 at risk
SYNCOPE	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0007 events7 affected135 at risk EG0012 events2 affected132 at risk EG0024 events2 affected78 at risk
ANXIETY	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG00021 events16 affected135 at risk EG0012 events2 affected132 at risk EG0025 events4 affected78 at risk
DEPRESSION	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG00011 events11 affected135 at risk EG0015 events5 affected132 at risk EG00210 events7 affected78 at risk
INSOMNIA	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG00022 events18 affected135 at risk EG00111 events9 affected132 at risk EG00211 events6 affected78 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG00013 events9 affected135 at risk EG0010 events0 affected132 at risk EG0022 events2 affected78 at risk
CHRONIC KIDNEY DISEASE	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG00012 events8 affected135 at risk EG0011 events1 affected132 at risk EG0020 events0 affected78 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG00014 events13 affected135 at risk EG0013 events3 affected132 at risk EG0028 events6 affected78 at risk
POLLAKIURIA	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0008 events8 affected135 at risk EG0014 events4 affected132 at risk EG0020 events0 affected78 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00079 events52 affected135 at risk EG00124 events20 affected132 at risk EG00225 events19 affected78 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00037 events21 affected135 at risk EG00116 events13 affected132 at risk EG00220 events11 affected78 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0008 events8 affected135 at risk EG0017 events6 affected132 at risk EG0024 events4 affected78 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00026 events21 affected135 at risk EG0018 events5 affected132 at risk EG0028 events7 affected78 at risk
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0009 events8 affected135 at risk EG0012 events2 affected132 at risk EG0023 events3 affected78 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00023 events16 affected135 at risk EG0015 events5 affected132 at risk EG0023 events3 affected78 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00017 events11 affected135 at risk EG0011 events1 affected132 at risk EG0025 events4 affected78 at risk
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0008 events8 affected135 at risk EG0012 events2 affected132 at risk EG0023 events3 affected78 at risk
ACTINIC KERATOSIS	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00019 events12 affected135 at risk EG0012 events2 affected132 at risk EG0022 events2 affected78 at risk
DECUBITUS ULCER	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected135 at risk EG0010 events0 affected132 at risk EG0028 events5 affected78 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00013 events12 affected135 at risk EG0013 events3 affected132 at risk EG0027 events4 affected78 at risk
ECCHYMOSIS	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0005 events3 affected135 at risk EG0011 events1 affected132 at risk EG00212 events9 affected78 at risk
NIGHT SWEATS	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00016 events14 affected135 at risk EG00112 events10 affected132 at risk EG0023 events3 affected78 at risk
PETECHIAE	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0008 events7 affected135 at risk EG0011 events1 affected132 at risk EG0025 events5 affected78 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00029 events19 affected135 at risk EG00113 events7 affected132 at risk EG00210 events5 affected78 at risk
PURPURA	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0008 events7 affected135 at risk EG0010 events0 affected132 at risk EG0023 events2 affected78 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00022 events9 affected135 at risk EG0018 events3 affected132 at risk EG0023 events3 affected78 at risk
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00030 events17 affected135 at risk EG0016 events6 affected132 at risk EG0024 events4 affected78 at risk
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00019 events13 affected135 at risk EG0017 events5 affected132 at risk EG00217 events6 affected78 at risk
SKIN LESION	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00013 events11 affected135 at risk EG0011 events1 affected132 at risk EG0025 events4 affected78 at risk
HYPERTENSION	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG00064 events37 affected135 at risk EG0010 events0 affected132 at risk EG00226 events10 affected78 at risk
HYPOTENSION	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected135 at risk EG0018 events6 affected132 at risk EG0028 events4 affected78 at risk

Ancestor Terms

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms