Study to Assess the Efficacy, Safety, and Tolerability of... | NCT04464564

NCT04464564

ID	Type	Description	Link
2020-000799-39	EudraCT Number
2023-504991-31-00	EU Trial (CTIS) Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants who were enrolled in 1-week double-blind placebo lead-in Period A, were then randomized to receive AVP-786 matching placebo capsules, twice a day, for 11 weeks in Period B.	Drug: Placebo
AVP-786-18	Experimental	Participants who were enrolled in 1-week double-blind placebo lead-in Period A, were then randomized to receive AVP-786-18 (d6-DM 18 milligrams (mg)/Q 4.9 mg) capsules, twice a day, for 11 weeks in Period B.	Drug: AVP-786
AVP-786-42.63	Experimental	Participants who were enrolled in 1-week double-blind placebo lead-in Period A, were then randomized to receive AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day, for 11 weeks in Period B.	Drug: AVP-786

Name	Type	Description	Arm Group Labels	Other Names
AVP-786	Drug	oral capsules	AVP-786-18 AVP-786-42.63

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From the End of Period A (Week 1) to Week 10 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score	The CMAI is used to assess the frequency of manifestations of agitated behaviors in elderly persons. It consists of 29 agitated behaviors that are further categorized into distinct agitation syndromes, also known as CMAI factors of agitation. These distinct agitation syndromes include aggressive behavior, physically nonaggressive behavior, and verbally agitated behavior. Each of the 29 items is rated on a 7-point scale of frequency (1 = never, 2 = less than once a week but still occurring, 3 = once or twice a week, 4 = several times a week, 5 = once or twice a day, 6 = several times a day, 7 = several times an hour). The ratings are based on the 2 weeks preceding assessment of the CMAI. Higher scores indicate higher frequency of agitated behaviours while lower scores indicate lower frequency of agitated behaviours.	Week 1 to Week 10
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAE	An adverse event (AE) is any untoward medical occurrence or unintended change (eg, physical, psychological, or behavioral), including inter-current illness, that does not necessarily have a causal relationship with the study treatment. A serious adverse event (SAE) is any AE occurring at any dose that results in death, life-threatening experience, persistent or significant disability/incapacity, in-patient hospitalization or prolongation of hospitalization or congenital anomaly/birth defect. TEAEs are all AEs (including serious and non-serious) which started after start of double-blind study drug treatment; or if the event was continuous from baseline and was worsening, serious, study drug related, or resulted in death, discontinuation, interruption or reduction of study therapy.	From randomization (Week 2) up to 30 days after last dose of study drug (Up to Week 16)

Secondary Outcomes

Measure	Description	Time Frame
Change From the End of Period A (Week 1) to Week 10 in the Clinical Global Impression of Severity of Illness (CGIS) Score, as Related to Agitation	The CGIS is an observer-rated scale that measures illness severity. The CGIS-Agitation is a 7-point (1-7) scale (1 = normal, not at all ill; 7 = among the most extremely ill patients) and assesses severity of agitation in this study. Higher scores indicate severe agitation while the lower scores indicate little or no agitation.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Site #840-020		Phoenix	Arizona	85004	United States
Clinical Research Site #840-047

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	All Enrolled	Participants received AVP-786 matching placebo capsules, twice a day, for 1 week in Period A.
FG001	Placebo	Participants who were enrolled in 1-week double-blind placebo lead-in Period A, were then randomized to receive AVP-786 matching placebo capsules, twice a day, for 11 weeks in Period B.

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	May 15, 2023	Apr 3, 2025

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants were enrolled in 1-week double-blind placebo lead-in Period A, and were then randomized to receive AVP-786 matching placebo capsules, twice a day, for 11 weeks in Period B.
BG001	AVP-786-18	Participants were enrolled in 1-week double-blind placebo lead-in Period A, and were then randomized to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules, twice a day, for 11 weeks in Period B.
BG002	AVP-786-42.63	Participants were enrolled in 1-week double-blind placebo lead-in Period A, and were then randomized to receive AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day, for 11 weeks in Period B.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00075.2± 7.27 BG00176.4± 7.50 BG00276.5± 7.43 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00042 BG00149 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
White	BG00060 BG00162 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Ethnicity

Title	Measurements
Hispanic or Latino	BG00039 BG00146 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 the End of Period A (Week 1) to Week 10 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score

The CMAI is used to assess the frequency of manifestations of agitated behaviors in elderly persons. It consists of 29 agitated behaviors that are further categorized into distinct agitation syndromes, also known as CMAI factors of agitation. These distinct agitation syndromes include aggressive behavior, physically nonaggressive behavior, and verbally agitated behavior. Each of the 29 items is rated on a 7-point scale of frequency (1 = never, 2 = less than once a week but still occurring, 3 = once or twice a week, 4 = several times a week, 5 = once or twice a day, 6 = several times a day, 7 = several times an hour). The ratings are based on the 2 weeks preceding assessment of the CMAI. Higher scores indicate higher frequency of agitated behaviours while lower scores indicate lower frequency of agitated behaviours.

Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified primary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed

Posted

Week 1 to Week 10

ID	Title	Description
OG000	Placebo	Participants were enrolled in 1-week double-blind placebo lead-in Period A, and were then randomized to receive AVP-786 matching placebo capsules, twice a day, for 11 weeks in Period B.
OG001	AVP-786-18	Participants were enrolled in 1-week double-blind placebo lead-in Period A, and were then randomized to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules, twice a day, for 11 weeks in Period B.
OG002	AVP-786-42.63	Participants were enrolled in 1-week double-blind placebo lead-in Period A, and were then randomized to receive AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day, for 11 weeks in Period B.

Units	Counts
Participants	OG0000 OG0010 OG0020

Primary

Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAE

An adverse event (AE) is any untoward medical occurrence or unintended change (eg, physical, psychological, or behavioral), including inter-current illness, that does not necessarily have a causal relationship with the study treatment. A serious adverse event (SAE) is any AE occurring at any dose that results in death, life-threatening experience, persistent or significant disability/incapacity, in-patient hospitalization or prolongation of hospitalization or congenital anomaly/birth defect. TEAEs are all AEs (including serious and non-serious) which started after start of double-blind study drug treatment; or if the event was continuous from baseline and was worsening, serious, study drug related, or resulted in death, discontinuation, interruption or reduction of study therapy.

Safety population included of all participants who were randomized in the double-blind period B of this study, and took at least one dose of double-blind, randomized study medication. As pre-specified in the Statistical Analysis Plan (SAP), safety data was planned to be collected only for the participants who were randomized in the double-blind period B of this study.

Posted

Count of Participants

Participants

From randomization (Week 2) up to 30 days after last dose of study drug (Up to Week 16)

ID	Title	Description
OG000	Placebo	Participants were enrolled in 1-week double-blind placebo lead-in Period A, and were then randomized to receive AVP-786 matching placebo capsules, twice a day, for 11 weeks in Period B.
OG001

Secondary

Change From the End of Period A (Week 1) to Week 10 in the Clinical Global Impression of Severity of Illness (CGIS) Score, as Related to Agitation

The CGIS is an observer-rated scale that measures illness severity. The CGIS-Agitation is a 7-point (1-7) scale (1 = normal, not at all ill; 7 = among the most extremely ill patients) and assesses severity of agitation in this study. Higher scores indicate severe agitation while the lower scores indicate little or no agitation.

Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed.

Posted

Week 1 to Week 10

ID	Title	Description
OG000	Placebo	Participants were enrolled in 1-week double-blind placebo lead-in Period A, and were then randomized to receive AVP-786 matching placebo capsules, twice a day, for 11 weeks in Period B.
OG001	AVP-786-18	Participants were enrolled in 1-week double-blind placebo lead-in Period A, and were then randomized to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules, twice a day, for 11 weeks in Period B.
OG002	AVP-786-42.63	Participants were enrolled in 1-week double-blind placebo lead-in Period A, and were then randomized to receive AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day, for 11 weeks in Period B.

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	Participants were enrolled in 1-week double-blind placebo lead-in Period A, and were then randomized to receive AVP-786 matching placebo capsules, twice a day, for 11 weeks in Period B.	1	76	4	76	25	76
EG001	AVP-786-18	Participants were enrolled in 1-week double-blind placebo lead-in Period A, and were then randomized to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules, twice a day, for 11 weeks in Period B.	0	83	5	83	38	83
EG002	AVP-786-42.63	Participants were enrolled in 1-week double-blind placebo lead-in Period A, and were then randomized to receive AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day, for 11 weeks in Period B.	1	77	5	77	32	77

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Oesophageal achalasia	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Vomiting	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Death	General disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
COVID-19	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Pneumonia	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Urinary tract infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Accidental exposure to product	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Dizziness	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0021 affected77 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Delirium	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Bradycardia	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0021 affected77 at risk
Palpitations	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Dry eye	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Constipation	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Nausea	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Toothache	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Vomiting	Gastrointestinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0021 affected77 at risk
Fatigue	General disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0014 affected83 at risk EG0021 affected77 at risk
Gait disturbance	General disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0023 affected77 at risk
Oedema	General disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Unevaluable event	General disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0021 affected77 at risk
Biliary cyst	Hepatobiliary disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Asymptomatic bacteriuria	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0022 affected77 at risk
Bacteriuria	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Bronchitis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
COVID-19	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0022 affected77 at risk
Gastroenteritis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Influenza	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0022 affected77 at risk
Nasopharyngitis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0012 affected83 at risk EG0020 affected77 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Periodontitis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Urinary tract infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0015 affected83 at risk EG0024 affected77 at risk
Viral infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Viral rhinitis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Wound infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Eye contusion	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0003 affected76 at risk EG0017 affected83 at risk EG0029 affected77 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Alanine aminotransferase abnormal	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Blood alkaline phosphatase abnormal	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Blood creatinine increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Blood glucose increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Blood potassium increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Blood triglycerides increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Blood urea increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Gamma-glutamyltransferase abnormal	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Heart rate decreased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Neutrophil count increased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Oesophagogastroduodenoscopy	Investigations	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
SARS-CoV-2 test positive	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Urine analysis abnormal	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Weight decreased	Investigations	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0011 affected83 at risk EG0021 affected77 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0012 affected83 at risk EG0020 affected77 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Insulin resistance	Metabolism and nutrition disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0021 affected77 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Essential thrombocythaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Akathisia	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Akinesia	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Dizziness	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0004 affected76 at risk EG0013 affected83 at risk EG0025 affected77 at risk
Dyslalia	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Headache	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0012 affected83 at risk EG0022 affected77 at risk
Hypersomnia	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Lethargy	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Presyncope	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Somnolence	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0024 affected77 at risk
Tremor	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Aggression	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0021 affected77 at risk
Agitation	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0021 affected77 at risk
Anxiety	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Behaviour disorder	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Confusional state	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Delirium	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Enuresis	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Hypnopompic hallucination	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Insomnia	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0012 affected83 at risk EG0022 affected77 at risk
Sleep talking	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Glycosuria	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected76 at risk EG0010 affected83 at risk EG0020 affected77 at risk
Hypercalciuria	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Polyuria	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0021 affected77 at risk
Prostatism	Reproductive system and breast disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Edentulous	Social circumstances	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0020 affected77 at risk
Hypertension	Vascular disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0013 affected83 at risk EG0020 affected77 at risk
Hypotension	Vascular disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0010 affected83 at risk EG0021 affected77 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected76 at risk EG0011 affected83 at risk EG0021 affected77 at risk

ID	Term
D011595	Psychomotor Agitation
D000544	Alzheimer Disease

ID	Term
D020820	Dyskinesias
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D011596	Psychomotor Disorders
D019954	Neurobehavioral Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D000096762	Aberrant Motor Behavior in Dementia
D001526	Behavioral Symptoms
D001519	Behavior
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D024801	Tauopathies
D019636	Neurodegenerative Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders