Study Evaluating The Long-Term Safety And Efficacy Of Sub... | NCT00916617

ID	Type	Description	Link
B2521009	Other Identifier	Alias Study Number

Status Module

Name	Class
JANSSEN Alzheimer Immunotherapy Research & Development, LLC	INDUSTRY

Label	Type	Description	Intervention Names
1	Experimental	5 mg/week	Drug: bapineuzumab

Name	Type	Description	Arm Group Labels	Other Names
bapineuzumab	Drug	5 mg/week subcutaneous bapineuzumab	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings	A brain Magnetic Resonance Imaging (MRI) was obtained from all participants at Week 13 and quarterly thereafter. Participants were to meet the following criteria: screening brain MRI scan is consistent with the diagnosis of Alzheimer's Disease. Screening diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria. Clinically significant MRIs were identified by the investigator. The number of participants with clinically significant MRIs are tabulated by visit and treatment group.	Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination		36 months

Eligibility Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Banner Alzheimer's Institute		Phoenix	Arizona	85006	United States
Pharmacology Research Institute

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Bapineuzumab (5 mg + 5 mg)	Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
FG001	Bapineuzumab (10 mg + 10 mg)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Bapineuzumab (5 mg + 5 mg)	Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
BG001	Bapineuzumab (10 mg + 10 mg)	Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
BG002	Placebo + Bapineuzumab 5mg	Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
BG003	Placebo + Bapineuzumab 10 mg	Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00023 BG00121 BG00210 BG0037 BG00461

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings

A brain Magnetic Resonance Imaging (MRI) was obtained from all participants at Week 13 and quarterly thereafter. Participants were to meet the following criteria: screening brain MRI scan is consistent with the diagnosis of Alzheimer's Disease. Screening diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria. Clinically significant MRIs were identified by the investigator. The number of participants with clinically significant MRIs are tabulated by visit and treatment group.

The safety population included all participants who received at least 1 dose of study medication in Study NCT00916617.

Posted

Number

Participants

Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit

ID	Title	Description
OG000	Bapineuzumab (5 mg + 5 mg)	Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
OG001	Bapineuzumab (10 mg + 10 mg)	Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
OG002	Placebo + Bapineuzumab 5mg	Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
OG003	Placebo + Bapineuzumab 10 mg	Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.

Units	Counts
Participants	OG00023 OG00121 OG00210 OG003

Title

Denominators

Categories

Week 13

Title	Measurements
	OG0000 OG0012 OG0021 OG003

Secondary

Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination

Because this study was terminated early, the planned pharmacokinetic analyses were not performed.

Posted

36 months

ID	Title	Description
OG000	Bapineuzumab (5 mg + 5 mg)	Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
OG001	Bapineuzumab (10 mg + 10 mg)	Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
OG002	Placebo + Bapineuzumab 5mg	Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
OG003	Placebo + Bapineuzumab 10 mg	Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bapineuzumab (5 mg + 5 mg)	Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.	4	23	19	23
EG001	Bapineuzumab (10 mg + 10 mg)	Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.	5	21	16	21
EG002	Placebo + Bapineuzumab 5mg	Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.	7	10	10	10
EG003	Placebo + Bapineuzumab 10 mg	Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.	2	7	6	7

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG0030 events0 affected7 at risk
Atrial flutter	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0010 events0 affected21 at risk EG0020 events0 affected10 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0010 events0 affected21 at risk EG0020 events0 affected10 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected21 at risk EG0020 events0 affected10 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0010 events0 affected21 at risk EG0020 events0 affected10 at risk EG003
Asthenia	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0010 events0 affected21 at risk EG0020 events0 affected10 at risk EG003
Chest pain	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0010 events0 affected21 at risk EG0020 events0 affected10 at risk EG003
Bronchitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Pneumonia	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0012 events1 affected21 at risk EG0020 events0 affected10 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected21 at risk EG0020 events0 affected10 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected21 at risk EG0020 events0 affected10 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0022 events2 affected10 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected21 at risk EG0020 events0 affected10 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0020 events0 affected10 at risk EG003
Syncope	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Depressive symptom	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected21 at risk EG0020 events0 affected10 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0010 events0 affected21 at risk EG0020 events0 affected10 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected21 at risk EG0020 events0 affected10 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG0030 events0 affected7 at risk
Constipation	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0010 events0 affected21 at risk EG0023 events3 affected10 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0002 events1 affected23 at risk EG0011 events1 affected21 at risk EG0022 events1 affected10 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected21 at risk EG0021 events1 affected10 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected23 at risk EG0010 events0 affected21 at risk EG0023 events3 affected10 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected23 at risk EG0010 events0 affected21 at risk EG0023 events3 affected10 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0012 events2 affected21 at risk EG0020 events0 affected10 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0013 events2 affected21 at risk EG0022 events2 affected10 at risk EG003
Asthenia	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Gait disturbance	General disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected23 at risk EG0014 events3 affected21 at risk EG0022 events1 affected10 at risk EG003
Injection site bruising	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0012 events1 affected21 at risk EG0020 events0 affected10 at risk EG003
Injection site reaction	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG00212 events1 affected10 at risk EG003
Oedema	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Oedema peripheral	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected21 at risk EG0022 events2 affected10 at risk EG003
Pyrexia	General disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected23 at risk EG0010 events0 affected21 at risk EG0020 events0 affected10 at risk EG003
Bacterial infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Bronchitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected23 at risk EG0012 events1 affected21 at risk EG0020 events0 affected10 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Mastoiditis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0022 events1 affected10 at risk EG003
Pneumonia	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Sinusitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0013 events3 affected21 at risk EG0021 events1 affected10 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0012 events2 affected21 at risk EG0022 events2 affected10 at risk EG003
Tooth infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected21 at risk EG0021 events1 affected10 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0009 events6 affected23 at risk EG0016 events4 affected21 at risk EG0021 events1 affected10 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected23 at risk EG0011 events1 affected21 at risk EG0025 events2 affected10 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0005 events2 affected23 at risk EG0011 events1 affected21 at risk EG0020 events0 affected10 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0018 events4 affected21 at risk EG0023 events2 affected10 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected23 at risk EG0011 events1 affected21 at risk EG0021 events1 affected10 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0020 events0 affected10 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0013 events2 affected21 at risk EG0020 events0 affected10 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected21 at risk EG0021 events1 affected10 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0020 events0 affected10 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0020 events0 affected10 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0006 events4 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected23 at risk EG0016 events4 affected21 at risk EG0023 events2 affected10 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected21 at risk EG0020 events0 affected10 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Action tremor	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Amnesia	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Aphasia	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0011 events1 affected21 at risk EG0020 events0 affected10 at risk EG003
Apraxia	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0012 events1 affected21 at risk EG0020 events0 affected10 at risk EG003
Bradykinesia	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected21 at risk EG0021 events1 affected10 at risk EG003
Cerebral microhaemorrhage	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Cogwheel rigidity	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Convulsion	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Coordination abnormal	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Dementia	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0020 events0 affected10 at risk EG003
Dementia Alzheimer's type	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0003 events2 affected23 at risk EG0011 events1 affected21 at risk EG0021 events1 affected10 at risk EG003
Dementia with Lewy bodies	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Dizziness	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0010 events0 affected21 at risk EG0022 events2 affected10 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0020 events0 affected10 at risk EG003
Dystonia	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Hyporeflexia	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0022 events1 affected10 at risk EG003
Masked facies	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Motor dysfunction	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Movement disorder	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0022 events1 affected10 at risk EG003
Sleep phase rhythm disturbance	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Somnolence	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected23 at risk EG0010 events0 affected21 at risk EG0022 events2 affected10 at risk EG003
Speech disorder	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0023 events2 affected10 at risk EG003
Vasogenic cerebral oedema	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0004 events3 affected23 at risk EG0010 events0 affected21 at risk EG0023 events2 affected10 at risk EG003
Agitation	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected23 at risk EG0012 events1 affected21 at risk EG0021 events1 affected10 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0013 events3 affected21 at risk EG0020 events0 affected10 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Depression	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0014 events3 affected21 at risk EG0021 events1 affected10 at risk EG003
Hallucination	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected23 at risk EG0011 events1 affected21 at risk EG0020 events0 affected10 at risk EG003
Hallucination, visual	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected21 at risk EG0021 events1 affected10 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0003 events2 affected23 at risk EG0012 events2 affected21 at risk EG0020 events0 affected10 at risk EG003
Nightmare	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Paranoia	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0012 events1 affected21 at risk EG0021 events1 affected10 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected21 at risk EG0021 events1 affected10 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected23 at risk EG0010 events0 affected21 at risk EG0020 events0 affected10 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0010 events0 affected21 at risk EG0020 events0 affected10 at risk EG003
Cough	Reproductive system and breast disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Dysphonia	Reproductive system and breast disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected21 at risk EG0021 events1 affected10 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0011 events1 affected21 at risk EG0021 events1 affected10 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected23 at risk EG0010 events0 affected21 at risk EG0022 events1 affected10 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected23 at risk EG0011 events1 affected21 at risk EG0020 events0 affected10 at risk EG003
Haemorrhage	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003
Hypotension	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected23 at risk EG0010 events0 affected21 at risk EG0021 events1 affected10 at risk EG003

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