A Study of Galantamine Used to Treat Patients With Mild t... | NCT00679627

ID	Type	Description	Link
GALALZ3005	Other Identifier	Janssen Research & Development, LLC

Status Module

Description Module

Detailed Description

This is a long-term (2-year), randomized (patients will be assigned to treatment by chance), double blind (neither the physician nor the patient will know which treatment is assigned) study of galantamine versus placebo in subjects with mild to moderately-severe AD. Approximately 2,000 patients will participate in this study. The study length for each patient is approximately 25.5 months. The study consists of 3 phases: a pretreatment phase, a treatment phase, and a posttreatment phase. The pretreatment phase includes a 2-week screening period (to obtain a patient's and his or her caregiver's informed consent and to confirm eligibility for the study) and a baseline visit at which subjects will be randomly assigned, in a 1 to 1 ratio, to receive either galantamine or placebo once a day in the morning. Study drug will first be dispensed at the baseline visit. The treatment phase is composed of a titration period (the study drug will be introduced gradually) and a maintenance period and includes 9 visits (3 of which are conducted by telephone). The titration period is 12 weeks long, and visits occur about every 28 days. In the first 4 weeks of the titration period, subjects will receive either 8 mg galantamine or matching placebo, and this dose will be increased to 16 mg galantamine or placebo in the second 4 weeks. The dose will then be increased to 24 mg galantamine or placebo for the final 4 weeks of the titration period if the investigator believes the subject will benefit from and will safely tolerate 24 mg/day. If not, the subject may continue to receive 16 mg galantamine or placebo through the end of the titration period. After the titration period, subjects will enter the maintenance period and continue to take study drug at the dosage they received at the end of the titration period. This dosage may be continued through the end of the study or may be changed once (either up from 16 to 24 mg or down from 24 to 16 mg), depending upon the benefit and the safety of such a change for the individual patient as judged by the investigator. No dosage will exceed 24 mg/day. The posttreatment phase includes an End-of-Study Visit that occurs at the end of the maintenance period. A follow-up telephone contact (interview) is conducted 1 month after the End-of-Study Visit. The effectiveness of galantamine will be evaluated using the following tools: the Mini-Mental State Examination (MMSE); the Disability Assessment in Dementia (DAD); and the Assessment of Patient Accommodation Status and Caregiver Burden (APAS CarB). Safety evaluations for the study include the monitoring of vital status and institutionalization status, adverse events, vital signs, weight, physical and neurologic examinations. A Data Safety Monitoring Board, external to the company, has been commissioned for this study to monitor the progress of the study and to ensure that the safety of patients is not compromised. The effectiveness hypothesis of this study is that galantamine, 16 to 24 mg per day, is superior to placebo in reducing cognitive decline from baseline (start of study drug) as measured by the MMSE over the course of 2 years. The safety hypothesis is that the mortality rate in the galantamine 16 to 24 mg per day treatment group will be the same as that in the placebo group over the course of 2 years.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Galantamine	Experimental	Galantamine 8mg/ day oral capsule increased to 16mg/day then to 24 mg per day	Drug: Galantamine
Placebo	Placebo Comparator	Matching placeco	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Galantamine	Drug	8mg/ day oral capsule increased to 16mg/day then to 24 mg per day	Galantamine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in the Mini-Mental State Examination (MMSE) Score	The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.	Baseline, Month 24
The Number of Deaths Reported in Participants	An external Data Safety Monitoring Board (DSMB) was assigned for this study to monitor the progress of the study and to ensure that the safety of participants was not compromised.	Up to 2 years

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in the Mini-Mental State Examination (MMSE) Score	The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.	Baseline, Month 6

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Janssen Research & Development, LLC C. Clinical Trial	Janssen Research & Development, LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39498781	Derived	Lim AWY, Schneider L, Loy C. Galantamine for dementia due to Alzheimer's disease and mild cognitive impairment. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD001747. doi: 10.1002/14651858.CD001747.pub4.
27846868	Derived	Hager K, Baseman AS, Nye JS, Brashear HR, Han J, Sano M, Davis B, Richards HM. Effect of concomitant use of memantine on mortality and efficacy outcomes of galantamine-treated patients with Alzheimer's disease: post-hoc analysis of a randomized placebo-controlled study. Alzheimers Res Ther. 2016 Nov 15;8(1):47. doi: 10.1186/s13195-016-0214-x.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
BG001	Galantamine	During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

participants

Title

Denominators

Categories

Title	Measurements
	BG00073.2± 8.67 BG00173± 8.88 BG00273.1± 8.77

Age, Customized

Number

participants

Title

Denominators

Categories

<61

Title	Measurements
	BG000112 BG001112 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000654 BG001671 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Czech Republic

Title	Measurements
	BG00033 BG00134 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in the Mini-Mental State Examination (MMSE) Score

The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.

An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the primary analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.

Posted

Mean

Standard Deviation

Scores on scale

Baseline, Month 24

ID	Title	Description
OG000	Placebo	During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
OG001	Galantamine	During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.

Units	Counts
Participants	OG000906 OG001906

Title

Denominators

Categories

Title	Measurements
	OG000-2.14± 4.340 OG001-1.41± 4.050

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		ANCOVA		<0.001													No	Superiority or Other

Primary

The Number of Deaths Reported in Participants

An external Data Safety Monitoring Board (DSMB) was assigned for this study to monitor the progress of the study and to ensure that the safety of participants was not compromised.

The safety analysis was performed on the safety population, ie, all randomized participants who received at least one dose of the study drug.

Posted

Number

Number of Participants

Up to 2 years

ID	Title	Description
OG000	Placebo	During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
OG001	Galantamine	During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.

Secondary

Change From Baseline in the Mini-Mental State Examination (MMSE) Score

Posted

Mean

Standard Deviation

Scores on scale

Baseline, Month 6

ID	Title	Description
OG000	Placebo	During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
OG001	Galantamine	During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.

Secondary

Change From Baseline in Disability Assessment in Dementia (DAD) Scores

The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities.

An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline DAD measure.

Posted

Mean

Standard Deviation

Scores on scale

Baseline, Month 24

ID	Title	Description
OG000	Placebo	During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
OG001	Galantamine

Secondary

Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)

The APAS-CarB is a measure used to evaluate participant status and caregiver burden. The table below presents Patient Accommodation assessed as the percentage of participants "home with friend or relative" using the APAS-CarB.

Posted

Number

Percentage of participants

Baseline, Months 12 and 24

ID	Title	Description
OG000	Placebo	During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
OG001	Galantamine	During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.

Secondary

Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)

The table below presents the number of days that caregiving activities were provided during the past week.

The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure.

Posted

Mean

Standard Deviation

Days

Baseline, Months 12 and 24

ID	Title	Description
OG000	Placebo	During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
OG001	Galantamine	During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.

Secondary

Change From Baseline in Institutional Status

This table describes the number of participants who were reported as institutionalized at baseline and Month 24.

The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure.

Posted

Number

Number of Participants

Baseline, Month 24

ID	Title	Description
OG000	Placebo	During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
OG001	Galantamine	During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.

Secondary

Change From Baseline in the Mini-Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)

The MMSE, is a validated, brief examination that rates subjects on orientation (total score, 10), registration (total score, 3), attention (total score, 5), calculation (total score, 5), recall (total score, 3), and language (total score, 9). The maximum score is 30 (only the higher of the two scores for attention and calculation [each with a maximum score of 5] was used). A higher score compared with baseline indicates less impairment.

The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.

Posted

Mean

Standard Deviation

Scores on scale

Baseline, Month 24

ID	Title	Description
OG000	Placebo	During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
OG001	Galantamine	During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.

Secondary

Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)

This analysis was performed in the intent-to-treat population which included all randomized participants who had at least 1 postbaseline DAD measure.

Posted

Mean

Standard Deviation

Scores on scale

Baseline, Month 24

ID	Title	Description
OG000	Placebo	During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
OG001	Galantamine

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	Placebo	During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.			123	1,021	115	1,021
EG001	Galantamine	During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.			129	1,024	168	1,024

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0011 affected1,024 at risk
Arrhythmia	Cardiac disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Arteriosclerosis Coronary Artery	Cardiac disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0011 affected1,024 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Bradycardia	Cardiac disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0011 affected1,024 at risk
Cardiac Arrest	Cardiac disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Cardiac Failure	Cardiac disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0003 affected1,021 at risk EG00110 affected1,024 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0002 affected1,021 at risk EG0012 affected1,024 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0003 affected1,021 at risk EG0010 affected1,024 at risk
Cardiopulmonary Failure	Cardiac disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0004 affected1,021 at risk EG0013 affected1,024 at risk
Cardiovascular Insufficiency	Cardiac disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0003 affected1,021 at risk EG0011 affected1,024 at risk
Ischaemic Cardiomyopathy	Cardiac disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Myocardial Infarction	Cardiac disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0002 affected1,021 at risk EG0016 affected1,024 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0011 affected1,024 at risk
Postinfarction Angina	Cardiac disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Vertigo	Ear and labyrinth disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Cataract	Eye disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0012 affected1,024 at risk
Cataract Subcapsular	Eye disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Glaucoma	Eye disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0012 affected1,024 at risk
Lens Disorder	Eye disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Anal Polyp	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Colitis Ischaemic	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Duodenal Ulcer Perforation	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Dysphagia	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Enterocolitis Haemorrhagic	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Faecal Incontinence	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Gastric Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0012 affected1,024 at risk
Haemorrhagic Erosive Gastritis	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Haemorrhoidal Haemorrhage	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Ileus	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0012 affected1,024 at risk
Intestinal Stenosis	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Oesophageal Achalasia	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Peritoneal Haemorrhage	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Varices Oesophageal	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0011 affected1,024 at risk
Abasia	General disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Death	General disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Hypothermia	General disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0002 affected1,021 at risk EG0010 affected1,024 at risk
Inflammation	General disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Multi-Organ Failure	General disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Oedema Peripheral	General disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Pyrexia	General disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0011 affected1,024 at risk
Sudden Death	General disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0003 affected1,021 at risk EG0011 affected1,024 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0012 affected1,024 at risk
Abscess	Infections and infestations	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Bronchitis	Infections and infestations	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0012 affected1,024 at risk
Bronchopneumonia	Infections and infestations	MedDRA Version 15.0	Non-systematic Assessment	EG0003 affected1,021 at risk EG0012 affected1,024 at risk
Clostridium Difficile Colitis	Infections and infestations	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Ear Infection	Infections and infestations	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Gastroenteritis Rotavirus	Infections and infestations	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Gastrointestinal Infection	Infections and infestations	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Herpes Zoster	Infections and infestations	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0012 affected1,024 at risk
Peritonitis	Infections and infestations	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Pneumonia	Infections and infestations	MedDRA Version 15.0	Non-systematic Assessment	EG0006 affected1,021 at risk EG0018 affected1,024 at risk
Post Procedural Infection	Infections and infestations	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Sepsis	Infections and infestations	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Tuberculosis	Infections and infestations	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0011 affected1,024 at risk
Urosepsis	Infections and infestations	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Accidental Overdose	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Carbon Monoxide Poisoning	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Chemical Poisoning	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Exposure to Toxic Agent	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0003 affected1,021 at risk EG0012 affected1,024 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0003 affected1,021 at risk EG0012 affected1,024 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0003 affected1,021 at risk EG0013 affected1,024 at risk
Forearm Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0011 affected1,024 at risk
Hand Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0002 affected1,021 at risk EG0011 affected1,024 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0003 affected1,021 at risk EG0011 affected1,024 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0012 affected1,024 at risk
Injury	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Joint Dislocation	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0011 affected1,024 at risk
Lower Limb Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0012 affected1,024 at risk
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Multiple Fractures	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Patella Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Skeletal Injury	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Spinal Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Subdural Haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Urethral Injury	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Wound Haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Blood Pressure Increased	Investigations	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Weight Decreased	Investigations	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0014 affected1,024 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0002 affected1,021 at risk EG0012 affected1,024 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0002 affected1,021 at risk EG0011 affected1,024 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Intervertebral Disc Compression	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0002 affected1,021 at risk EG0011 affected1,024 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0012 affected1,024 at risk
Spinal Column Stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Spinal Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Adenocarcinoma Pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0011 affected1,024 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0011 affected1,024 at risk
Hepatic Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Pancreatic Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Pharyngeal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Prostatic Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Rectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Salivary Gland Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Altered State of Consciousness	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Cerebral Arteriosclerosis	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0011 affected1,024 at risk
Cerebral Infarction	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0002 affected1,021 at risk EG0011 affected1,024 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0002 affected1,021 at risk EG0014 affected1,024 at risk
Cerebrovascular Disorder	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0011 affected1,024 at risk
Coma	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Dementia	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0002 affected1,021 at risk EG0010 affected1,024 at risk
Dementia Alzheimer's Type	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG00012 affected1,021 at risk EG0019 affected1,024 at risk
Diabetic Neuropathy	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Epilepsy	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0003 affected1,021 at risk EG0010 affected1,024 at risk
Haemorrhage Intracranial	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Haemorrhagic Stroke	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0008 affected1,021 at risk EG0012 affected1,024 at risk
Loss of Consciousness	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0013 affected1,024 at risk
Polyneuropathy	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Presyncope	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Speech Disorder	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Syncope	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0003 affected1,021 at risk EG0013 affected1,024 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0003 affected1,021 at risk EG0012 affected1,024 at risk
Vertebrobasilar Insufficiency	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Abnormal Behaviour	Psychiatric disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Adjustment Disorder	Psychiatric disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Aggression	Psychiatric disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0013 affected1,024 at risk
Agitation	Psychiatric disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0002 affected1,021 at risk EG0011 affected1,024 at risk
Catatonia	Psychiatric disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Confusional State	Psychiatric disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Delirium	Psychiatric disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0011 affected1,024 at risk
Depression	Psychiatric disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Disorientation	Psychiatric disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Psychotic Disorder	Psychiatric disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0012 affected1,024 at risk
Restlessness	Psychiatric disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Suicide Attempt	Psychiatric disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Incontinence	Renal and urinary disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Nephritis	Renal and urinary disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Renal Failure Chronic	Renal and urinary disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Stress Urinary Incontinence	Renal and urinary disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Tubulointerstitial Nephritis	Renal and urinary disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Urinary Incontinence	Renal and urinary disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Urinary Retention	Renal and urinary disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0011 affected1,024 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0012 affected1,024 at risk
Pelvic Pain	Reproductive system and breast disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Scrotal Disorder	Reproductive system and breast disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Vulval Leukoplakia	Reproductive system and breast disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Acute Lung Injury	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Bronchitis Chronic	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0012 affected1,024 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0015 affected1,024 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Decubitus Ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Carotid Artery Stent Removal	Surgical and medical procedures	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Arteriosclerosis	Vascular disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Circulatory Collapse	Vascular disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Essential Hypertension	Vascular disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0012 affected1,024 at risk
Haemorrhagic Infarction	Vascular disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Hypertension	Vascular disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0011 affected1,024 at risk
Hypertensive Crisis	Vascular disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0000 affected1,021 at risk EG0011 affected1,024 at risk
Hypotension	Vascular disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Malignant Hypertension	Vascular disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0011 affected1,024 at risk
Pallor	Vascular disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA Version 15.0	Non-systematic Assessment	EG0001 affected1,021 at risk EG0010 affected1,024 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vertigo	Ear and labyrinth disorders	MedDRA Version 15.0	Non-systematic Assessment	EG00048 affected1,021 at risk EG00157 affected1,024 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 15.0	Non-systematic Assessment	EG00024 affected1,021 at risk EG00185 affected1,024 at risk
Headache	Nervous system disorders	MedDRA Version 15.0	Non-systematic Assessment	EG00058 affected1,021 at risk EG00158 affected1,024 at risk

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies
D019636	Neurodegenerative Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Facility	Status	City	State	ZIP	Country	Contacts
		Hradec Králové			Czechia

ID	Term
D000544	Alzheimer Disease
D008569	Memory Disorders

ID	Term
D047151	Amaryllidaceae Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring