Efficacy and Safety Study of Darolutamide (ODM-201) in Me... | NCT02200614

NCT02200614

ID	Type	Description	Link
2013-003820-36	EudraCT Number

Status Module

Name	Class
Orion Corporation, Orion Pharma	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Darolutamide (BAY1841788)	Experimental	Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.	Drug: Darolutamide (Nubeqa, BAY1841788)
Placebo	Placebo Comparator	Participants received matching placebo 2 tablets twice daily with food.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Darolutamide (Nubeqa, BAY1841788)	Drug	Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.	Darolutamide (BAY1841788)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Metastasis-Free Survival	Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first (cut-off date 15 Nov 2019)	From randomization to the time approximately 385 MFS events were observed (approximately 48 months)

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival - Primary Analysis	Overall Survival (OS) was defined as the time from randomization to death due to any cause.	From randomization of the first subject to the time approximatively 140 death events were observed (approximately 48 months)
Time to Pain Progression - Primary Analysis

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
Castration-resistant prostate cancer (CRPC) with castrate level of serum testosterone.
Prostate-specific Antigen (PSA) doubling time of ≤ 10 months and PSA > 2ng/ml.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Blood counts at screening: haemoglobin ≥ 9.0 g/dl,absolute neutrophil count ≥ 1500/µl, platelet count ≥ 100,000/µl.
Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, creatinine ≤ 2.0 x ULN.
Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment.

Exclusion Criteria:

History of metastatic disease at any time or presence of detectable metastases.
Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation.
Prior treatment with: second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor.
Use of estrogens or 5-α reductase inhibitors or AR inhibitors.
Prior chemotherapy or immunotherapy for prostate cancer.
Use of systemic corticosteroid.
Radiation therapy within 12 weeks before randomisation.
Severe or uncontrolled concurrent disease, infection or co-morbidity.
Treatment with bisphosphonate or denosumab within 12 weeks before randomisation.
Known hypersensitivity to the study treatment or any of its ingredients.
Major surgery within 28 days before randomisation.
Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.
Uncontrolled hypertension.
Prior malignancy.
Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease.
Treatment with any investigational drug within 28 days before randomisation.
Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Homewood	Alabama	35209	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41450200	Derived	Saar M, Fizazi K, Shore ND, Smith M, Damber JE, Semenov A, Ribal MJ, Birtle A, Rigaud J, Wallis CJD, Grimm MO, Halabi S, Armstrong AJ, Mohamed AF, Adorjan P, Srinivasan S, Verholen F, Morgans AK, Siemens DR. Effects of Prior Local Therapy by Radical Prostatectomy or Radiotherapy on the Efficacy and Quality of Life of Patients Treated With Darolutamide in ARAMIS. Cancer Med. 2026 Jan;15(1):e71343. doi: 10.1002/cam4.71343.
40132221

Label	URL
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Darolutamide (BAY1841788)	Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 6, 2019	Apr 3, 2020

Arm/Group Information

ID	Title	Description
BG000	Darolutamide (BAY1841788)	Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).
BG001	Placebo	Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).
BG002	Total	Total of all reporting groups

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

Metastasis-Free Survival

Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first (cut-off date 15 Nov 2019)

Posted

Median

95% Confidence Interval

months

From randomization to the time approximately 385 MFS events were observed (approximately 48 months)

ID	Title	Description
OG000	Darolutamide (BAY1841788)	Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).
OG001	Placebo	Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).

Units	Counts
Participants	OG000955 OG001554

Title

Denominators

Categories

Title	Measurements
	OG00040.37(34.33 to NA)NA = value cannot be estimated due to censored data, insufficient number of participants with events OG00118.43(15.51 to 22.34)

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		<0.000001		Hazard Ratio (HR)	0.413			2-Sided	95	0.341	0.500			Hazard ratio and 95% Confidence Interval (CI) was based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. > 6 months) and use of osteoclast-targeted therapy (No, Yes).		Superiority

Secondary

Overall Survival - Primary Analysis

Overall Survival (OS) was defined as the time from randomization to death due to any cause.

Posted

Median

95% Confidence Interval

months

From randomization of the first subject to the time approximatively 140 death events were observed (approximately 48 months)

ID	Title	Description
OG000	Darolutamide (BAY1841788)	Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).
OG001	Placebo	Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).

Units	Counts
Participants	OG000

Secondary

Time to Pain Progression - Primary Analysis

Time to pain progression (PP) is defined as time from randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline in question 3 of the Brief Pain Inventory-Short Form questionnaire (BPI-SF) related to the worst pain in the last 24 hours taken as a 7-day average for post-baseline scores, or initiation of short or long-acting opioids for pain, whichever comes first. Initiation or change in the use of other non-opioid analgesics is not used in the analysis of pain progression.

Posted

Median

95% Confidence Interval

months

From randomization until last study treatment (assessed every 4 months) (approximately 48 months)

ID	Title	Description
OG000	Darolutamide (BAY1841788)	Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).
OG001	Placebo	Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).

Secondary

Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Primary Analysis

The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle.

Posted

Median

95% Confidence Interval

months

From randomization until last study treatment (assessed every 4 months) (approximately 48 months)

ID	Title	Description
OG000	Darolutamide (BAY1841788)	Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).
OG001	Placebo	Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).

Units	Counts
Participants	OG000

Secondary

Time to First Symptomatic Skeletal Event (SSE) - Primary Analysis

The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE.

Posted

Median

95% Confidence Interval

months

From randomization until last study treatment (assessed every 4 months) (approximately 48 months)

ID	Title	Description
OG000	Darolutamide (BAY1841788)	Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).
OG001	Placebo	Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).

Units	Counts
Participants	OG000

Secondary

Overall Survival - Final Analysis

Overall Survival (OS) was defined as the time from randomization to death due to any cause. The final analysis was done at the time of the data cut-off (15 NOV 2019).

Posted

Median

95% Confidence Interval

months

From randomization of the first subject to the time approximatively 254 death events were observed (approximately 56 months)

ID	Title	Description
OG000	Darolutamide (BAY1841788)	Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).
OG001	Placebo	Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).

Units	Counts
Participants	OG000

Secondary

Time to Pain Progression - Final Analysis

For time to pain progression, the analysis performed using the primary completion cut-off data (03 SEP 2018) was considered final and no new analysis was performed for time to pain progression.

Posted

Median

95% Confidence Interval

months

From randomization until last study treatment (assessed every 4 months) (approximately 48 months)

ID	Title	Description
OG000	Darolutamide (BAY1841788)	Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).
OG001	Placebo	Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).

Units	Counts
Participants	OG000

Secondary

Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Final Analysis

The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle. The final analysis was done at the time of the data cut-off (15 NOV 2019).

Posted

Median

95% Confidence Interval

months

From randomization until initiation of first cytotoxic chemotherapy treatment (approximately 59 months)

ID	Title	Description
OG000	Darolutamide (BAY1841788)	Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).
OG001	Placebo	Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).

Units	Counts
Participants

Secondary

Time to First Symptomatic Skeletal Event (SSE) - Final Analysis

The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE. The final analysis was done at the time of the data cut-off (15 NOV 2019).

Posted

Median

95% Confidence Interval

months

From randomization until occurrence of first SSE event (approximately 59 months)

ID	Title	Description
OG000	Darolutamide (BAY1841788)	Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).
OG001	Placebo	Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Darolutamide (DB)	Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg (double blind [DB]).	155	954	251	954	673	954
EG001	Darolutamide (DB+OL)	Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind [DB] + open-label [OL]).	224	954	367	954	742	954
EG002	Placebo (DB)	Participants received matching placebo 2 tablets twice daily with food (double blind [DB]).	137	554	121	554	354	554
EG003	Placebo+Darolutamide (CO)	Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over [CO]).	16	170	43	170	110	170

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0004 events3 affected954 at risk EG0019 events8 affected954 at risk EG0020 events0 affected554 at risk EG0031 events1 affected170 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events2 affected954 at risk EG0021 events1 affected554 at risk EG003
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Immune thrombocytopenia	Blood and lymphatic system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0020 events0 affected554 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0005 events5 affected954 at risk EG0016 events6 affected954 at risk EG0020 events0 affected554 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0005 events4 affected954 at risk EG0015 events4 affected954 at risk EG0022 events2 affected554 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0021 events1 affected554 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0013 events3 affected954 at risk EG0021 events1 affected554 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0013 events3 affected954 at risk EG0020 events0 affected554 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG00011 events8 affected954 at risk EG00112 events9 affected954 at risk EG0023 events3 affected554 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Bradycardia	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0021 events1 affected554 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0023 events3 affected554 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0009 events8 affected954 at risk EG00114 events12 affected954 at risk EG0025 events4 affected554 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0013 events3 affected954 at risk EG0020 events0 affected554 at risk EG003
Conduction disorder	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0003 events2 affected954 at risk EG0015 events4 affected954 at risk EG0021 events1 affected554 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Hypertensive heart disease	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0004 events4 affected954 at risk EG00112 events11 affected954 at risk EG0023 events2 affected554 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0014 events3 affected954 at risk EG0021 events1 affected554 at risk EG003
Palpitations	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Cardiac disorder	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Aortic valve disease	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Cardiovascular insufficiency	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events1 affected954 at risk EG0012 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Pyloric stenosis	Congenital, familial and genetic disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Cataract	Eye disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0020 events0 affected554 at risk EG003
Glaucoma	Eye disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Retinal detachment	Eye disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Retinal vascular disorder	Eye disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Visual impairment	Eye disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Macular hole	Eye disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0020 events0 affected554 at risk EG003
Abdominal mass	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0013 events3 affected954 at risk EG0021 events1 affected554 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0003 events2 affected954 at risk EG0015 events3 affected954 at risk EG0020 events0 affected554 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0014 events3 affected954 at risk EG0021 events1 affected554 at risk EG003
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Gastrointestinal pain	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Intestinal infarction	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0012 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0004 events4 affected954 at risk EG0014 events4 affected954 at risk EG0020 events0 affected554 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Pancreatic cyst	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Plicated tongue	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Proctitis	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0003 events3 affected954 at risk EG0013 events3 affected954 at risk EG0020 events0 affected554 at risk EG003
Rectal stenosis	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0016 events3 affected954 at risk EG0023 events2 affected554 at risk EG003
Small intestinal perforation	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events1 affected954 at risk EG0012 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0020 events0 affected554 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Pneumoperitoneum	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Anal haemorrhage	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0023 events1 affected554 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0003 events3 affected954 at risk EG0013 events3 affected954 at risk EG0021 events1 affected554 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Enterovesical fistula	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Bowel movement irregularity	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Hiatus hernia, obstructive	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Asthenia	General disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Chest pain	General disorders	MedDRA (24.0)	Non-systematic Assessment	EG0003 events3 affected954 at risk EG0013 events3 affected954 at risk EG0020 events0 affected554 at risk EG003
Death	General disorders	MedDRA (24.0)	Non-systematic Assessment	EG0004 events4 affected954 at risk EG0016 events6 affected954 at risk EG0021 events1 affected554 at risk EG003
Gait disturbance	General disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Pyrexia	General disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Sudden death	General disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Sudden cardiac death	General disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
General physical health deterioration	General disorders	MedDRA (24.0)	Non-systematic Assessment	EG0007 events5 affected954 at risk EG00111 events7 affected954 at risk EG0020 events0 affected554 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0021 events1 affected554 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0021 events1 affected554 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Cholestasis	Hepatobiliary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events1 affected954 at risk EG0012 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Liver disorder	Hepatobiliary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Bile duct stenosis	Hepatobiliary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Biliary obstruction	Hepatobiliary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0021 events1 affected554 at risk EG003
Appendicitis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0021 events1 affected554 at risk EG003
Bronchitis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Cellulitis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0012 events2 affected954 at risk EG0021 events1 affected554 at risk EG003
Cellulitis gangrenous	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0022 events1 affected554 at risk EG003
Dengue fever	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0012 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Endocarditis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0002 events1 affected954 at risk EG0012 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Erysipelas	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0013 events3 affected954 at risk EG0020 events0 affected554 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0022 events2 affected554 at risk EG003
Hepatitis C	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Infectious mononucleosis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Influenza	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0021 events1 affected554 at risk EG003
Meningitis bacterial	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Perinephric abscess	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Pneumonia	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG00018 events15 affected954 at risk EG00124 events20 affected954 at risk EG0026 events6 affected554 at risk EG003
Pneumonia pneumococcal	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Pneumonia staphylococcal	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0003 events3 affected954 at risk EG0013 events3 affected954 at risk EG0020 events0 affected554 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0003 events2 affected954 at risk EG0014 events3 affected954 at risk EG0021 events1 affected554 at risk EG003
Sepsis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0013 events3 affected954 at risk EG0020 events0 affected554 at risk EG003
Septic shock	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0002 events1 affected954 at risk EG0013 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Sialoadenitis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Tick-borne viral encephalitis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0020 events0 affected554 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0007 events7 affected954 at risk EG00113 events12 affected954 at risk EG0020 events0 affected554 at risk EG003
Vestibular neuronitis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Wound infection	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Urosepsis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0003 events2 affected954 at risk EG00110 events4 affected954 at risk EG0020 events0 affected554 at risk EG003
Acute endocarditis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Urinary tract infection bacterial	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Abdominal sepsis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0020 events0 affected554 at risk EG003
Wound abscess	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0020 events0 affected554 at risk EG003
Klebsiella bacteraemia	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Intervertebral discitis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Abdominal abscess	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Bacterial infection	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Arthritis infective	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0020 events0 affected554 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Severe acute respiratory syndrome	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Cholecystitis infective	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Device related infection	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Medical device site infection	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0020 events0 affected554 at risk EG003
Varicella zoster virus infection	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0002 events1 affected954 at risk EG0012 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Medical device site joint infection	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0002 events1 affected954 at risk EG0012 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
COVID-19	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0017 events4 affected954 at risk EG0020 events0 affected554 at risk EG003
Diverticulitis intestinal perforated	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0015 events4 affected954 at risk EG0020 events0 affected554 at risk EG003
Suspected COVID-19	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0013 events3 affected954 at risk EG0020 events0 affected554 at risk EG003
Bite	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0021 events1 affected554 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0003 events3 affected954 at risk EG0014 events4 affected954 at risk EG0021 events1 affected554 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0014 events4 affected954 at risk EG0021 events1 affected554 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0021 events1 affected554 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0013 events3 affected954 at risk EG0020 events0 affected554 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Multiple injuries	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Radiation proctitis	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0003 events2 affected954 at risk EG0015 events4 affected954 at risk EG0021 events1 affected554 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0014 events4 affected954 at risk EG0021 events1 affected554 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Stenosis of vesicourethral anastomosis	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Vascular procedure complication	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Heart injury	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Skull fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Flatback syndrome	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Incarcerated parastomal hernia	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Biopsy prostate	Investigations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Blood creatinine increased	Investigations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0021 events1 affected554 at risk EG003
Body temperature increased	Investigations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Prostatic specific antigen increased	Investigations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Transaminases increased	Investigations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0020 events0 affected554 at risk EG003
Urine output decreased	Investigations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Angiocardiogram	Investigations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0022 events2 affected554 at risk EG003
Cachexia	Metabolism and nutrition disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (24.0)	Non-systematic Assessment	EG0004 events3 affected954 at risk EG0014 events3 affected954 at risk EG0021 events1 affected554 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events1 affected954 at risk EG0012 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (24.0)	Non-systematic Assessment	EG0004 events4 affected954 at risk EG0014 events4 affected954 at risk EG0020 events0 affected554 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0021 events1 affected554 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Kyphosis	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG0003 events3 affected954 at risk EG0014 events4 affected954 at risk EG0021 events1 affected554 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0020 events0 affected554 at risk EG003
Rapidly progressive osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Benign hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0004 events3 affected954 at risk EG0015 events4 affected954 at risk EG0020 events0 affected554 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0020 events0 affected554 at risk EG003
Carcinoid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Choroid melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0004 events3 affected954 at risk EG0014 events3 affected954 at risk EG0020 events0 affected554 at risk EG003
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0022 events2 affected554 at risk EG003
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0020 events0 affected554 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0020 events0 affected554 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0003 events3 affected954 at risk EG0013 events3 affected954 at risk EG0020 events0 affected554 at risk EG003
Pituitary tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0003 events2 affected954 at risk EG0013 events2 affected954 at risk EG0021 events1 affected554 at risk EG003
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Thymoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0020 events0 affected554 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events2 affected954 at risk EG0021 events1 affected554 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0013 events3 affected954 at risk EG0021 events1 affected554 at risk EG003
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0020 events0 affected554 at risk EG003
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Neuroendocrine tumour of the lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Autonomic nervous system imbalance	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Bulbar palsy	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0013 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0013 events3 affected954 at risk EG0020 events0 affected554 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0022 events1 affected554 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0016 events6 affected954 at risk EG0023 events3 affected554 at risk EG003
Dizziness	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0021 events1 affected554 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0022 events1 affected554 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Myelopathy	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Normal pressure hydrocephalus	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Presyncope	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events1 affected954 at risk EG0012 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Seizure	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Syncope	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events2 affected954 at risk EG0022 events2 affected554 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0014 events4 affected954 at risk EG0022 events1 affected554 at risk EG003
Brain oedema	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Perineurial cyst	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
IIIrd nerve disorder	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0006 events5 affected954 at risk EG0016 events5 affected954 at risk EG0022 events2 affected554 at risk EG003
Partial seizures	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Parkinson's disease	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Vertebrobasilar stroke	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Delirium	Psychiatric disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Depression	Psychiatric disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Major depression	Psychiatric disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events1 affected954 at risk EG0013 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Azotaemia	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Calculus bladder	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0023 events3 affected554 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG00013 events11 affected954 at risk EG00129 events25 affected954 at risk EG0027 events7 affected554 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0003 events3 affected954 at risk EG00110 events8 affected954 at risk EG0024 events4 affected554 at risk EG003
Nephritis	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0013 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Oliguria	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events1 affected954 at risk EG0012 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0013 events3 affected954 at risk EG0020 events0 affected554 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0014 events4 affected954 at risk EG0024 events4 affected554 at risk EG003
Ureteric obstruction	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0020 events0 affected554 at risk EG003
Ureteric stenosis	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG00017 events16 affected954 at risk EG00137 events33 affected954 at risk EG00220 events20 affected554 at risk EG003
Urinary tract disorder	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Urine flow decreased	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0021 events1 affected554 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0009 events7 affected954 at risk EG00113 events11 affected954 at risk EG0023 events3 affected554 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0012 events2 affected954 at risk EG0022 events2 affected554 at risk EG003
Urethral stenosis	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0004 events4 affected954 at risk EG0017 events7 affected954 at risk EG0023 events3 affected554 at risk EG003
Lower urinary tract symptoms	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Bladder outlet obstruction	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0013 events3 affected954 at risk EG0021 events1 affected554 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Prostatic obstruction	Reproductive system and breast disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0021 events1 affected554 at risk EG003
Prostate induration	Reproductive system and breast disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Perineal pain	Reproductive system and breast disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0003 events2 affected954 at risk EG0013 events2 affected954 at risk EG0025 events3 affected554 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0025 events3 affected554 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0005 events4 affected954 at risk EG0016 events5 affected954 at risk EG0022 events2 affected554 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0003 events3 affected954 at risk EG0013 events3 affected954 at risk EG0021 events1 affected554 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0005 events5 affected954 at risk EG0017 events7 affected954 at risk EG0021 events1 affected554 at risk EG003
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0021 events1 affected554 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Skin mass	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Angioplasty	Surgical and medical procedures	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Bladder catheterisation	Surgical and medical procedures	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Hip arthroplasty	Surgical and medical procedures	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0021 events1 affected554 at risk EG003
Inguinal hernia repair	Surgical and medical procedures	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Orchidectomy	Surgical and medical procedures	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Transurethral prostatectomy	Surgical and medical procedures	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0021 events1 affected554 at risk EG003
Nephrostomy	Surgical and medical procedures	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Coronary angioplasty	Surgical and medical procedures	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Artificial urinary sphincter implant	Surgical and medical procedures	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Radiotherapy to brain	Surgical and medical procedures	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Prostatectomy	Surgical and medical procedures	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Pulmonary resection	Surgical and medical procedures	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Aortic dissection	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0003 events3 affected954 at risk EG0013 events3 affected954 at risk EG0020 events0 affected554 at risk EG003
Aortic thrombosis	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Hypertension	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Hypotension	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Lymphoedema	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Thrombosis	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Subclavian vein thrombosis	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0010 events0 affected954 at risk EG0021 events1 affected554 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Iliac artery stenosis	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Embolism	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected954 at risk EG0011 events1 affected954 at risk EG0020 events0 affected554 at risk EG003
Device dislocation	Product Issues	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0022 events1 affected554 at risk EG003
Device occlusion	Product Issues	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected954 at risk EG0012 events2 affected954 at risk EG0020 events0 affected554 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (24.0)	Non-systematic Assessment	EG00076 events60 affected954 at risk EG001136 events93 affected954 at risk EG00233 events28 affected554 at risk EG0037 events7 affected170 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (24.0)	Non-systematic Assessment	EG00017 events13 affected954 at risk EG00127 events21 affected954 at risk EG0024 events4 affected554 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG00020 events19 affected954 at risk EG00130 events26 affected954 at risk EG0028 events6 affected554 at risk EG003
Cataract	Eye disorders	MedDRA (24.0)	Non-systematic Assessment	EG00011 events11 affected954 at risk EG00116 events15 affected954 at risk EG0026 events5 affected554 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG00027 events25 affected954 at risk EG00139 events35 affected954 at risk EG00214 events12 affected554 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG00016 events14 affected954 at risk EG00119 events16 affected954 at risk EG00215 events14 affected554 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG00070 events65 affected954 at risk EG00194 events84 affected954 at risk EG00241 events36 affected554 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG00087 events69 affected954 at risk EG001114 events87 affected954 at risk EG00237 events33 affected554 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG00059 events53 affected954 at risk EG00176 events60 affected954 at risk EG00237 events32 affected554 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG00019 events17 affected954 at risk EG00124 events21 affected954 at risk EG00212 events10 affected554 at risk EG003
Asthenia	General disorders	MedDRA (24.0)	Non-systematic Assessment	EG00042 events37 affected954 at risk EG00153 events43 affected954 at risk EG00223 events20 affected554 at risk EG003
Fatigue	General disorders	MedDRA (24.0)	Non-systematic Assessment	EG000164 events126 affected954 at risk EG001198 events142 affected954 at risk EG00260 events47 affected554 at risk EG003
Oedema peripheral	General disorders	MedDRA (24.0)	Non-systematic Assessment	EG00049 events43 affected954 at risk EG00167 events57 affected954 at risk EG00219 events17 affected554 at risk EG003
Pyrexia	General disorders	MedDRA (24.0)	Non-systematic Assessment	EG00025 events18 affected954 at risk EG00128 events21 affected954 at risk EG0027 events5 affected554 at risk EG003
Bronchitis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG00017 events13 affected954 at risk EG00130 events23 affected954 at risk EG00210 events9 affected554 at risk EG003
Influenza	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG00033 events28 affected954 at risk EG00142 events36 affected954 at risk EG0028 events8 affected554 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG00050 events39 affected954 at risk EG00178 events56 affected954 at risk EG00227 events23 affected554 at risk EG003
Pneumonia	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG00011 events10 affected954 at risk EG00124 events22 affected954 at risk EG0025 events5 affected554 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG00029 events26 affected954 at risk EG00140 events34 affected954 at risk EG00213 events10 affected554 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG00059 events44 affected954 at risk EG001130 events73 affected954 at risk EG00237 events31 affected554 at risk EG003
COVID-19	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected954 at risk EG0016 events6 affected954 at risk EG0020 events0 affected554 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG00044 events41 affected954 at risk EG00169 events62 affected954 at risk EG00227 events23 affected554 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG00017 events16 affected954 at risk EG00130 events28 affected954 at risk EG00210 events8 affected554 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG00017 events12 affected954 at risk EG00126 events21 affected954 at risk EG0022 events2 affected554 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (24.0)	Non-systematic Assessment	EG0008 events6 affected954 at risk EG00116 events13 affected954 at risk EG0021 events1 affected554 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (24.0)	Non-systematic Assessment	EG00016 events12 affected954 at risk EG00129 events23 affected954 at risk EG0021 events1 affected554 at risk EG003
Blood creatinine increased	Investigations	MedDRA (24.0)	Non-systematic Assessment	EG00032 events23 affected954 at risk EG00151 events37 affected954 at risk EG00219 events14 affected554 at risk EG003
Weight decreased	Investigations	MedDRA (24.0)	Non-systematic Assessment	EG00042 events40 affected954 at risk EG00172 events65 affected954 at risk EG00217 events14 affected554 at risk EG003
Weight increased	Investigations	MedDRA (24.0)	Non-systematic Assessment	EG00015 events14 affected954 at risk EG00127 events25 affected954 at risk EG0028 events7 affected554 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (24.0)	Non-systematic Assessment	EG00024 events16 affected954 at risk EG00132 events22 affected954 at risk EG00210 events9 affected554 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (24.0)	Non-systematic Assessment	EG00010 events10 affected954 at risk EG00113 events12 affected954 at risk EG0022 events2 affected554 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (24.0)	Non-systematic Assessment	EG00034 events30 affected954 at risk EG00149 events40 affected954 at risk EG00218 events16 affected554 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG000146 events106 affected954 at risk EG001190 events135 affected954 at risk EG00269 events58 affected554 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG000104 events92 affected954 at risk EG001142 events118 affected954 at risk EG00259 events52 affected554 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG00020 events19 affected954 at risk EG00121 events20 affected954 at risk EG0024 events4 affected554 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG00021 events18 affected954 at risk EG00128 events24 affected954 at risk EG0028 events7 affected554 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG00020 events16 affected954 at risk EG00133 events26 affected954 at risk EG0023 events3 affected554 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG00079 events60 affected954 at risk EG001105 events71 affected954 at risk EG00225 events19 affected554 at risk EG003
Dizziness	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG00047 events39 affected954 at risk EG00164 events48 affected954 at risk EG00217 events14 affected554 at risk EG003
Headache	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG00059 events41 affected954 at risk EG00175 events53 affected954 at risk EG00215 events14 affected554 at risk EG003
Depression	Psychiatric disorders	MedDRA (24.0)	Non-systematic Assessment	EG00020 events20 affected954 at risk EG00127 events25 affected954 at risk EG00210 events9 affected554 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (24.0)	Non-systematic Assessment	EG00028 events26 affected954 at risk EG00138 events35 affected954 at risk EG00211 events11 affected554 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG00027 events24 affected954 at risk EG00137 events32 affected954 at risk EG00230 events27 affected554 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG00048 events37 affected954 at risk EG00196 events66 affected954 at risk EG00239 events27 affected554 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG00017 events14 affected954 at risk EG00125 events21 affected954 at risk EG0024 events4 affected554 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG00017 events17 affected954 at risk EG00124 events23 affected954 at risk EG00210 events10 affected554 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG00046 events41 affected954 at risk EG00163 events51 affected954 at risk EG00220 events18 affected554 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG00015 events15 affected954 at risk EG00125 events24 affected954 at risk EG00214 events14 affected554 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG00027 events25 affected954 at risk EG00147 events39 affected954 at risk EG00229 events24 affected554 at risk EG003
Gynaecomastia	Reproductive system and breast disorders	MedDRA (24.0)	Non-systematic Assessment	EG00021 events21 affected954 at risk EG00130 events30 affected954 at risk EG0026 events6 affected554 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA (24.0)	Non-systematic Assessment	EG00015 events13 affected954 at risk EG00119 events16 affected954 at risk EG00213 events12 affected554 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG00034 events29 affected954 at risk EG00138 events33 affected954 at risk EG00211 events11 affected554 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG00028 events26 affected954 at risk EG00134 events32 affected954 at risk EG00222 events16 affected554 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG00020 events17 affected954 at risk EG00125 events22 affected954 at risk EG00214 events12 affected554 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Non-systematic Assessment	EG00017 events17 affected954 at risk EG00127 events24 affected954 at risk EG0024 events4 affected554 at risk EG003
Hypertension	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG00086 events66 affected954 at risk EG001117 events87 affected954 at risk EG00239 events31 affected554 at risk EG003
Hot flush	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG00058 events54 affected954 at risk EG00173 events67 affected954 at risk EG00225 events25 affected554 at risk EG003