Study Evaluating The Efficacy And Safety Of Bapineuzumab... | NCT00667810

NCT00667810

ID	Type	Description	Link
B2521001	Other Identifier	Alias Study Number
2007-005994-79	EudraCT Number

Status Module

Label	Type	Intervention Names
Bapineuzumab 0.5 mg/kg	Experimental	Drug: bapineuzumab
Bapineuzumab 1.0 mg/kg	Experimental	Drug: bapineuzumab
Placebo	Placebo Comparator	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
bapineuzumab	Drug	Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.	Bapineuzumab 0.5 mg/kg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78	The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.	78 weeks
The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78	The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement.	78 weeks

Secondary Outcomes

Measure	Description	Time Frame
The Change From Baseline in Brain Amyloid Burden at Week 71.	Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PiB) positron emission tomography (PET). The latter is a semiquantitative measure of the extent of fibrillar amyloid in the brain. PIB PET measurements were made in cortical regions found to have the highest burden of fibrillar amyloid at autopsy in participants diagnosed as having Alzheimer's pathology, and also regions reported to have the highest average retention of PIB signal in previous PET studies enrolling participants with probable AD. This parameter reflects overall brain amyloid deposition as indexed by imaging. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by PIB PET imaging in a subset of participants.

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama-Birmingham		Birmingham	Alabama	35294	United States
Dedicated Clinical Research

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27176461	Derived	Vandenberghe R, Rinne JO, Boada M, Katayama S, Scheltens P, Vellas B, Tuchman M, Gass A, Fiebach JB, Hill D, Lobello K, Li D, McRae T, Lucas P, Evans I, Booth K, Luscan G, Wyman BT, Hua L, Yang L, Brashear HR, Black RS; Bapineuzumab 3000 and 3001 Clinical Study Investigators. Bapineuzumab for mild to moderate Alzheimer's disease in two global, randomized, phase 3 trials. Alzheimers Res Ther. 2016 May 12;8(1):18. doi: 10.1186/s13195-016-0189-7.
26297092

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 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by intravenous (IV) infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
FG001	Bapineuzumab 1.0 mg/kg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Bapineuzumab 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
BG001	Bapineuzumab 1.0 mg/kg	Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
BG002	Placebo	Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
BG003	Bapineuzumab 2.0 mg/kg	Participants received 2.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
BG004	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78

The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.

The modified intent-to-treat (mITT) included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and Disability Assessment for Dementia (DAD) total score.

Posted

Least Squares Mean

Standard Error

Units on a scale

78 weeks

ID	Title	Description
OG000	Bapineuzumab 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG001	Bapineuzumab 1.0 mg/kg	Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG002	Placebo	Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.

Units	Counts
Participants	OG000255 OG001253 OG002328

Title

Denominators

Categories

Title	Measurements
	OG0006.05± 0.71 OG0018.07± 0.73 OG0027.88± 0.64

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Change from baseline in ADAS-Cog/11 total score was analyzed using a restricted maximum likelihood (REML) based mixed model for repeated-measures (MMRM). The number of participants in each group provided approximately 90% power to detect a 2.65 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.	Mixed Models Analysis		0.057	The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.	Mean Difference (Final Values)	-1.83			2-Sided	95	-3.71	0.05				No

Primary

The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78

The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement.

The Modified Intent-to-Treat (mITT) population included as all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.

Posted

Least Squares Mean

Standard Error

Units on a scale

78 weeks

ID	Title	Description
OG000	Bapineuzumab 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG001

Secondary

The Change From Baseline in Brain Amyloid Burden at Week 71.

Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PiB) positron emission tomography (PET). The latter is a semiquantitative measure of the extent of fibrillar amyloid in the brain. PIB PET measurements were made in cortical regions found to have the highest burden of fibrillar amyloid at autopsy in participants diagnosed as having Alzheimer's pathology, and also regions reported to have the highest average retention of PIB signal in previous PET studies enrolling participants with probable AD. This parameter reflects overall brain amyloid deposition as indexed by imaging. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by PIB PET imaging in a subset of participants.

PiB PET population included all randomized participants who enrolled in the PET substudies and who met the following criteria: a) received at least one infusion or portion of an infusion of study drug, b) had a baseline and at least one post baseline PiB PET assessment, and c) had an SUVr for the global cortical average (GCA) ROI≥1.35 at baseline.

Posted

Least Squares Mean

Standard Error

SUVr

71 Weeks

ID	Title	Description
OG000	Bapineuzumab 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG001	Bapineuzumab 1.0 mg/kg

Secondary

The Change From Baseline in Phospho-tau Levels in the Cerebrospinal Fluid (CSF) at Week 71.

Biomarkers CSF phospho-tau (p-tau) is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. Accordingly, a reduction from baseline in levels of CSF tau in participants who received bapineuzumab compared with participants who received placebo may be indicative of a reduction in neuronal loss in participants treated with bapineuzumab.

CSF population included all randomized participants who enrolled in the CSF substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline CSF measurement (CSF phospho-tau).

Posted

Least Squares Mean

Standard Error

pg/mL

71 Weeks

ID	Title	Description
OG000	Bapineuzumab 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG001	Bapineuzumab 1.0 mg/kg	Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.

Secondary

The Change From Baseline in Brain Volume at Week 71

Brain volume was examined in a subset of participants by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI). Cerebral atrophy correlates closely with the gradual cognitive decline in AD and can be visualized by MRI. The BBSI technique involves positional matching of serial 3-dimensional MRI brain images, such that brain MRI-image volumes were first registered and then subtracted from each other. Atrophy rates would generally be expected to be lower if the underlying disease was attenuated by effective treatment.

The vMRI population Included all randomized participants who enrolled in the vMRI substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline vMRI that passed quality control and was satisfactory for volumetric analysis.

Posted

Least Squares Mean

Standard Error

mL/year

71 Weeks

ID	Title	Description
OG000	Bapineuzumab 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG001	Bapineuzumab 1.0 mg/kg	Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.

Secondary

Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78

The MMRM estimated slope (based on linear contrasts) of the differences between bapineuzumab and placebo for the ADAS-Cog/11 total scores from Week 39 to Week 78 was presented.

The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.

Posted

Mean

Standard Error

Units/Year

39 Weeks

ID	Title	Description
OG000	Bapineuzumab 0.5 mg/kg - Placebo	For the ADAS-Cog/11 total score, results are presented from a REML based MMRM.
OG001	Bapineuzumab 1.0 mg/kg - Placebo	For the ADAS-Cog/11 total score, results are presented from a REML based MMRM.

Units	Counts
Participants	OG000

Secondary

Divergence of Effect on the DAD Total Scores From Week 39 to Week 78

The MMRM estimated slope (based on linear contrasts)of the differences between bapineuzumab and placebo for the DAD total scores from Week 39 to Week 78 was presented.

Posted

Mean

Standard Error

Units/Years

39 weeks

ID	Title	Description
OG000	Bapineuzumab 0.5 mg/kg - Placebo	For the DAD total score, results are presented from a REML-based MMRM.
OG001	Bapineuzumab 1.0 mg/kg - Placebo	For the DAD total score, results are presented from a REML)-based MMRM.

Units	Counts
Participants	OG000

Secondary

Time to Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)

The time to first median placebo deterioration (for the EU) was defined as the first time a subject experienced an increase from baseline (worsening) in ADAS Cog/11 total score greater than or equal to the median worsening observed at Week 78 in the placebo group. The Kaplan Meier estimate of the median time to first median placebo deterioration in ADAS Cog/11 total score was presented.

Posted

Median

95% Confidence Interval

Days

78 Weeks

ID	Title	Description
OG000	Bapineuzumab 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG001	Bapineuzumab 1.0 mg/kg	Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG002

Secondary

Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)

The time to first clinically meaningful deterioration (for the US) was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of >=7.

Posted

Median

95% Confidence Interval

Days

78 weeks

ID	Title	Description
OG000	Bapineuzumab 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG001	Bapineuzumab 1.0 mg/kg	Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG002	Placebo	Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.

Secondary

Time to Median Placebo Deterioration on DAD Total Score

The time to first median placebo deterioration (for the EU) was defined as the first time a participant experienced a decrease (worsening) in DAD total score greater than or equal to the median worsening at Week 78 in the placebo group.

Posted

Median

95% Confidence Interval

Days

78 Weeks

ID	Title	Description
OG000	Bapineuzumab 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG001	Bapineuzumab 1.0 mg/kg	Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG002	Placebo	Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.

Secondary

Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis Plan)

The time to first clinically meaningful deterioration was defined as the first time a participant experienced a decrease (worsening)from baseline in DAD total score of >=12.

Posted

Median

95% Confidence Interval

Days

78 Weeks

ID	Title	Description
OG000	Bapineuzumab 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG001	Bapineuzumab 1.0 mg/kg	Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG002	Placebo	Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.

Secondary

Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (European Union Analysis Plan)

Percentage of participants whose increase (worsening) in ADAS-Cog/11 total score from baseline to Week 78 was at most 0, 3, 7 points.

Posted

Number

95% Confidence Interval

Number of participants

78 Weeks

ID	Title	Description
OG000	Bapineuzumab 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG001	Bapineuzumab 1.0 mg/kg	Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG002	Placebo	Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.

Secondary

Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)

Percentage of participants whose increase (worsening) from baseline to Week 78 in ADAS-Cog/11 total score is <7.

Posted

Number

Percentage of participants

78 Weeks

ID	Title	Description
OG000	Bapineuzumab 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG001	Bapineuzumab 1.0 mg/kg	Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG002	Placebo	Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.

Secondary

Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (European Union Analysis Plan)

Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was at most 0, 6, 12 points.

Posted

Number

95% Confidence Interval

Percentage of participants

78 Weeks

ID	Title	Description
OG000	Bapineuzumab 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG001	Bapineuzumab 1.0 mg/kg	Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG002	Placebo	Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.

Secondary

Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (US Analysis Plan)

Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was <12.

Posted

Number

Percentage of participants

78 weeks

ID	Title	Description
OG000	Bapineuzumab 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG001	Bapineuzumab 1.0 mg/kg	Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG002	Placebo	Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.

Secondary

Change From Baseline in Dependence Scale Total Score at Week 78

The Dependence Scale (DS) is a 13-item, caregiver-rated instrument for determining the amount of support required by a participant with AD. The DS total score ranges from 0 to 15, with higher scores indicating more need for assistance. The DS was administered as an interview to the caregiver at scheduled study visits.

Posted

Least Squares Mean

Standard Error

Units on a scale

78 Weeks

ID	Title	Description
OG000	Bapineuzumab 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG001	Bapineuzumab 1.0 mg/kg	Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG002	Placebo

Secondary

Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78

The CDR-SOB is a global clinical staging instrument that sums 6 clinical ratings: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the Clinical Dementia Rating Scale (CDR) interview. The CDR includes discussions with the participant and caregiver using a structured format. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. CDR-SOB total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates an improvement.

Posted

Least Squares Mean

Standard Error

Units on a scale

78 Weeks

ID	Title	Description
OG000	Bapineuzumab 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
OG001	Bapineuzumab 1.0 mg/kg	Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bapineuzumab 0.5 mg/kg	Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.	32	267	109	267
EG001	Bapineuzumab 1.0 mg/kg	Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.	34	263	123	263
EG002	Placebo	Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.	53	344	124	344
EG003	Bapineuzumab 2.0 mg/kg	Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.	2	11	9	11

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG0030 events0 affected11 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Acute left ventricular failure	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Adams-Stokes syndrome	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0012 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Cataract	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0013 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Faecal incontinence	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Death	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
General physical health deterioration	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Granuloma	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0012 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Anal abscess	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Appendicitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Herpes zoster oticus	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Meningitis viral	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Otitis media	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Periorbital cellulitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Pneumonia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0021 events1 affected344 at risk EG003
Sepsis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Urosepsis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0022 events2 affected344 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Heat illness	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0022 events1 affected344 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Skull fractured base	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0022 events2 affected344 at risk EG003
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
ECG signs of myocardial ischaemia	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Liver function test abnormal	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Weight decreased	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0003 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0002 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0024 events2 affected344 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0002 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0022 events1 affected344 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0022 events2 affected344 at risk EG003
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Aphasia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Cerebral microhaemorrhage	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Convulsion	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Dementia Alzheimer's type	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Dizziness	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Headache	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Intracranial hypotension	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0021 events1 affected344 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Perineurial cyst	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Presyncope	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Quadriparesis	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Senile dementia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Status epilepticus	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Subdural hygroma	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Syncope	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0011 events1 affected263 at risk EG0021 events1 affected344 at risk EG003
Vasogenic cerebral oedema	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0008 events6 affected267 at risk EG00120 events12 affected263 at risk EG0020 events0 affected344 at risk EG003
Abnormal behaviour	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0022 events1 affected344 at risk EG003
Aggression	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Agitation	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Alcohol abuse	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Alcoholic psychosis	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0021 events1 affected344 at risk EG003
Delirium	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0021 events1 affected344 at risk EG003
Depression	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Hallucination	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Impulsive behaviour	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Jealous delusion	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Prostatitis	Reproductive system and breast disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0025 events2 affected344 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0024 events1 affected344 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Aortic thrombosis	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003
Deep vein thrombosis	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Peripheral artery stenosis	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0021 events1 affected344 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Tachycardia	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0022 events2 affected344 at risk EG0031 events1 affected11 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Vision blurred	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0014 events1 affected263 at risk EG0021 events1 affected344 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG00016 events6 affected267 at risk EG0016 events6 affected263 at risk EG00210 events9 affected344 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0008 events8 affected267 at risk EG0017 events7 affected263 at risk EG00215 events11 affected344 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG00011 events9 affected267 at risk EG00111 events9 affected263 at risk EG00212 events10 affected344 at risk EG003
Catheter site haematoma	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0012 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG00023 events17 affected267 at risk EG00124 events18 affected263 at risk EG00244 events28 affected344 at risk EG003
Sinusitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG00016 events5 affected267 at risk EG0013 events3 affected263 at risk EG0025 events3 affected344 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG00017 events15 affected267 at risk EG00117 events13 affected263 at risk EG00213 events9 affected344 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0007 events6 affected267 at risk EG00110 events8 affected263 at risk EG0021 events1 affected344 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG00025 events18 affected267 at risk EG00118 events16 affected263 at risk EG00226 events18 affected344 at risk EG003
Blood pressure increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0005 events5 affected267 at risk EG0019 events5 affected263 at risk EG0027 events6 affected344 at risk EG003
Hypophagia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG00015 events6 affected267 at risk EG00117 events5 affected263 at risk EG0029 events6 affected344 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Aphasia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0014 events2 affected263 at risk EG0026 events2 affected344 at risk EG003
Ataxia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Balance disorder	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 at risk EG003
Cerebral microhaemorrhage	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG00013 events11 affected267 at risk EG00141 events22 affected263 at risk EG00221 events9 affected344 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Dizziness	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0008 events8 affected267 at risk EG00120 events7 affected263 at risk EG00217 events16 affected344 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0022 events1 affected344 at risk EG003
Exertional headache	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Headache	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG00019 events17 affected267 at risk EG00136 events15 affected263 at risk EG00236 events29 affected344 at risk EG003
Hyporeflexia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Mental impairment	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Parkinson's disease	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Vasogenic cerebral oedema	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG00016 events7 affected267 at risk EG00143 events20 affected263 at risk EG0027 events2 affected344 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0004 events4 affected267 at risk EG0015 events3 affected263 at risk EG0026 events6 affected344 at risk EG003
Depression	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG00025 events13 affected267 at risk EG00121 events11 affected263 at risk EG00224 events9 affected344 at risk EG003
Hallucination	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected267 at risk EG0012 events2 affected263 at risk EG0022 events2 affected344 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected267 at risk EG0010 events0 affected263 at risk EG0020 events0 affected344 at risk EG003
Hypertension	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0008 events8 affected267 at risk EG00112 events10 affected263 at risk EG00216 events9 affected344 at risk EG003
Hypotension	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected267 at risk EG0011 events1 affected263 at risk EG0020 events0 affected344 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