A Long Term Extension Study Evaluating ACC-001 With QS-21... | NCT00960531

ID	Type	Description	Link
B2571008	Other Identifier	Alias Study Number

Name	Class
JANSSEN Alzheimer Immunotherapy Research & Development, LLC	INDUSTRY

Label	Type	Description	Intervention Names
ACC-001 (3mcg) + QS-21	Experimental	ACC-001 (3mcg) + QS-21	Biological: ACC-001+ QS21 (3mcg)
ACC-001 (10mcg) + QS-21	Experimental	ACC-001 (10mcg) + QS-21	Biological: ACC-001 (10 mcg) + QS-21
ACC-001 (30mcg) + QS-21	Experimental	ACC-001 (30mcg) + QS-21	Biological: ACC-001+QS-21 (30mcg)

Name	Type	Description	Arm Group Labels	Other Names
ACC-001+ QS21 (3mcg)	Biological	ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo	ACC-001 (3mcg) + QS-21

Measure	Description	Time Frame
Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	24 months

Measure	Description	Time Frame
GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	IgM was not statistically analyzed.	Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable)

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
Banner Boswell Medical Center

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

ID	Title	Description
FG000	ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
FG001	QS-21 / ACC 3 µg+QS-21

Arm/Group Information

ID	Title	Description
BG000	ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG001	QS-21 / ACC 3 µg+QS-21	Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG002	ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG003	ACC 10 µg / ACC 10 µg+QS-21	Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG004	QS-21 / ACC 10 µg+QS-21	Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG005	PBS / ACC 10 μg+QS-21	Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG006	ACC 30 µg+QS-21 / ACC 30 µg+QS-21	Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG007	ACC 30 µg / ACC 30 µg+QS-21	Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG008	QS-21 / ACC 30 µg+QS-21	Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG009	PBS / ACC 30 μg+QS-21	Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG010	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Other Pre-specified

GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

IgM was not statistically analyzed.

IgM was not assessed.

Posted

Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

ID	Title	Description
OG000	ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG001	QS-21 / ACC 3 µg+QS-21	Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG002	ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Participants 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG003	ACC 10 µg / ACC 10 µg+QS-21	Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG004	QS-21 / ACC 10 µg+QS-21	Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG005	PBS / ACC 10 μg+QS-21	Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG006	ACC 30 μg+QS-21 / ACC 30 μg+QS-21	Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG007	ACC 30 μg / ACC 30 μg+QS-21	Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG008	QS-21 / ACC 30 μg+QS-21	Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG009	PBS / ACC 30 μg+QS-21	Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Other Pre-specified

Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable)

IgG subtypes were not assessed

IgG subtypes were not assessed.

Posted

Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

ID	Title	Description
OG000	ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG001	QS-21 / ACC 3 µg+QS-21	Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG002	ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG003

Primary

Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)

An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

All participants who received at least one dose of the study drug were included in the safety population. For safety analyses, the participants were summarized according to the combination of treatments they actually received during the 3134K1-200-EU or 3134K1-2201-US lead-in studies and 3134K1-2203-EU or 3134K1-2205-US extension studies.

Posted

Number

percentage of participants

24 months

ID	Title	Description
OG000	ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG001	QS-21 / ACC 3 µg+QS-21

Other Pre-specified

Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.

The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.

Posted

Geometric Mean

95% Confidence Interval

U/ml

Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

ID	Title	Description
OG000	ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG001	QS-21 / ACC 3 µg+QS-21	Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG002	ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.	6	21	19	21
EG001	QS-21 / ACC 3 µg+QS-21	Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.	0	6	6	6
EG002	Active / ACC 10 µg+QS-21	Participants received 10 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 alone in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.	16	65	55	65
EG003	Control / ACC 10µg+QS-21	Participants received 50 μg of QS-21 or PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.	2	14	13	14
EG004	Active / ACC 30 µg+QS-21	Participants received 30 μg of ACC-001 and 50 μg of QS-21 or 30 μg of ACC-001 alone in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.	4	33	23	33
EG005	Control / ACC 30 μg+QS-21	Participants received 50 μg of QS-21 or PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.	4	20	17	20

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Syncope	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG0031 affected14 at risk EG0042 affected33 at risk EG0051 affected20 at risk
Cerebral haemosiderin deposition	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Dementia Alzheimers type	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Dysarthria	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Partial seizures	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Vasogenic cerebral oedema	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Bradyarrhythmia	Cardiac disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Cyanosis	Cardiac disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Mitral valve prolapse	Cardiac disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Chest pain	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Device dislocation	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Pelvic mass	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Abnormal behaviour	Psychiatric disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Agitated depression	Psychiatric disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Agitation	Psychiatric disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Gallbladder cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Calculus ureteric	Renal and urinary disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Raynauds phenomenon	Vascular disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Cataract	Eye disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Biliary colic	Hepatobiliary disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Liver function test abnormal	Investigations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Skin haemorrhage	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site pain	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0004 affected21 at risk EG0010 affected6 at risk EG00211 affected65 at risk EG0032 affected14 at risk EG0045 affected33 at risk EG0056 affected20 at risk
Injection site erythema	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0004 affected21 at risk EG0010 affected6 at risk EG0025 affected65 at risk EG003
Injection site swelling	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0003 affected21 at risk EG0010 affected6 at risk EG0025 affected65 at risk EG003
Fatigue	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected21 at risk EG0011 affected6 at risk EG0024 affected65 at risk EG003
Injection site bruising	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Injection site haemorrhage	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Injection site pruritus	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0024 affected65 at risk EG003
Injection site induration	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0003 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Injection site inflammation	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0022 affected65 at risk EG003
Asthenia	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0003 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Induration	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Face oedema	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Inflammation	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Injection site hypersensitivity	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0014 affected6 at risk EG0029 affected65 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0002 affected21 at risk EG0011 affected6 at risk EG0026 affected65 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0023 affected65 at risk EG003
Bronchitis	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0003 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected6 at risk EG0022 affected65 at risk EG003
Rhinitis	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0022 affected65 at risk EG003
Sinusitis	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected6 at risk EG0020 affected65 at risk EG003
Onychomycosis	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected6 at risk EG0020 affected65 at risk EG003
Infected bites	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected6 at risk EG0020 affected65 at risk EG003
Influenza	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Localised infection	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected6 at risk EG0020 affected65 at risk EG003
Lyme disease	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Pneumonia	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected6 at risk EG0020 affected65 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Wound infection	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Agitation	Psychiatric disorders	MedDRA 17.0	Non-systematic Assessment	EG0003 affected21 at risk EG0014 affected6 at risk EG0025 affected65 at risk EG003
Depression	Psychiatric disorders	MedDRA 17.0	Non-systematic Assessment	EG0003 affected21 at risk EG0010 affected6 at risk EG0023 affected65 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected21 at risk EG0010 affected6 at risk EG0024 affected65 at risk EG003
Aggression	Psychiatric disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected6 at risk EG0022 affected65 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0024 affected65 at risk EG003
Irritability	Psychiatric disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected6 at risk EG0021 affected65 at risk EG003
Abnormal behaviour	Psychiatric disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Delirium	Psychiatric disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Delusional perception	Psychiatric disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Nightmare	Psychiatric disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected6 at risk EG0020 affected65 at risk EG003
Dizziness	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected21 at risk EG0010 affected6 at risk EG0025 affected65 at risk EG003
Headache	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0026 affected65 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected6 at risk EG0020 affected65 at risk EG003
Myoclonus	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected6 at risk EG0022 affected65 at risk EG003
Syncope	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected21 at risk EG0010 affected6 at risk EG0022 affected65 at risk EG003
Dementia Alzheimers type	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected6 at risk EG0021 affected65 at risk EG003
Tremor	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Balance disorder	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Hyperreflexia	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected6 at risk EG0020 affected65 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Lethargy	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0004 affected21 at risk EG0011 affected6 at risk EG0023 affected65 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0023 affected65 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0003 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0022 affected65 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Faeces soft	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected6 at risk EG0020 affected65 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected6 at risk EG0020 affected65 at risk EG003
Periodontal disease	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0004 affected21 at risk EG0011 affected6 at risk EG0027 affected65 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0003 affected21 at risk EG0011 affected6 at risk EG0022 affected65 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0023 affected65 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Eye contusion	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Periorbital contusion	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected6 at risk EG0020 affected65 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0024 affected65 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0024 affected65 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected6 at risk EG0024 affected65 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0023 affected65 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0024 affected65 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0023 affected65 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0024 affected65 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0022 affected65 at risk EG003
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Hypertension	Vascular disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0023 affected65 at risk EG003
Hypotension	Vascular disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0025 affected65 at risk EG003
Haematoma	Vascular disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Haemorrhage	Vascular disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected21 at risk EG0011 affected6 at risk EG0023 affected65 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected6 at risk EG0023 affected65 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected6 at risk EG0020 affected65 at risk EG003
Weight decreased	Investigations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Bartonella test positive	Investigations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Urine output decreased	Investigations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected6 at risk EG0020 affected65 at risk EG003
Vitamin B1 decreased	Investigations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Cataract	Eye disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Glaucoma	Eye disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Heterophoria	Eye disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Retinal degeneration	Eye disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0021 affected65 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected6 at risk EG0020 affected65 at risk EG003
Hearing impaired	Ear and labyrinth disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 at risk EG003
Testicular pain	Reproductive system and breast disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected21 at risk EG0010 affected6 at risk EG0020 affected65 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

ID	Term
C000603458	vanutide cridificar
C078785	saponin QA-21V1