Effects of LY450139, on the Progression of Alzheimer's Di... | NCT00762411 | Trialant
NCT00762411
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Feb 16, 2015Estimated
Enrollment
1,111Actual
Phase
Phase 3
Conditions
Alzheimer's Disease
Interventions
LY450139
Placebo
Countries
United States
Brazil
Bulgaria
Canada
China
France
Germany
Hungary
Italy
Japan
Mexico
Romania
Russia
Serbia
South Korea
Taiwan
Turkey (Türkiye)
Ukraine
Protocol Section
Identification Module
NCT ID
NCT00762411
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
11271
Secondary IDs
ID
Type
Description
Link
H6L-MC-LFBC
Other Identifier
Eli Lilly and Company
Brief Title
Effects of LY450139, on the Progression of Alzheimer's Disease as Compared With Placebo
Official Title
Effect of LY450139 a y-Secretase Inhibitor, on the Progression of Alzheimer's Disease as Compared With Placebo
Acronym
IDENTITY-2
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jan 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2008
Primary Completion Date
Apr 2011Actual
Completion Date
Apr 2011Actual
First Submitted Date
Sep 26, 2008
First Submission Date that Met QC Criteria
Sep 26, 2008
First Posted Date
Sep 30, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 6, 2013
Results First Submitted that Met QC Criteria
Sep 22, 2014
Results First Posted Date
Sep 25, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Aug 22, 2011
Certification/Extension First Submitted that Passed QC Review
Aug 22, 2011
Certification/Extension First Posted Date
Aug 23, 2011Estimated
Last Update Submitted Date
Jan 28, 2015
Last Update Posted Date
Feb 16, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta amyloid (β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (γ-secretase) lowers the production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in blood, spinal fluid and brain in animals tested thus far. This study used several different tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some patients. The buildup of amyloid plaques was measured by a brain scan that takes a picture of amyloid plaques in the brain. Other tests measured the overall function of the brain and brain size in some patients. In this trial, patients who initially received placebo (inactive sugar pill) were, at a certain point in the study, switched over to active drug, semagacestat. In other words, all patients could eventually receive active drug. Each patient's participation could last approximately 2 years. Patients taking approved AD medications were permitted to participate in this study and continue taking these medications during the study. All patients who completed this study had the option to continue receiving semagacestat by participating in an open label study.
Preliminary results from this study (LFBC) (and another similar study LFAN [NCT00594568]) showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. LFBC, LFAN and open label LFBF (NCT01035138) have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol.
Detailed Description
Not provided
Conditions Module
Conditions
Alzheimer's Disease
Keywords
Alzheimer's Disease
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,111Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LY450139
Experimental
Participants received 60 milligrams (mg) LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Drug: LY450139
Placebo
Placebo Comparator
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY450139
Drug
Administered orally once daily.
LY450139
Semagacestat
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 76 Weeks
The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Baseline (randomization), 76 weeks
Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 16 Weeks After Cessation of Study Drug
The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Baseline (randomization), 16 weeks following treatment cessation
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 76 Weeks
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Baseline (randomization), 76 weeks
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 16 Weeks After Cessation of Study Drug
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 76 Weeks
CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Meets criteria for mild to moderate Alzheimer's disease (AD) with Mini-Mental State Examination score of 16 through 26 at visit 1
Modified Hachinski Ischemia Scale score of less than or equal to 4
Geriatric Depression Scale score of less than or equal to 6
A magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2 years with no findings inconsistent with a diagnosis of AD
If female, must be without menstruation for a least 12 consecutive months or have had both ovaries removed.
Exclusion Criteria:
Is not capable of swallowing whole oral medication
Has serious or unstable illnesses
Does not have a reliable caregiver
Chronic alcohol and/or drug abuse within the past 5 years
Has ever had a active vaccination for AD
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
55 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon - Fri 9 AM - 5 PM eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Baseline (randomization), 16 weeks following treatment cessation
Baseline (randomization), 76 weeks
Change From Baseline in Neuropsychiatric Inventory (NPI) at 76 Weeks
NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 12 to 144; higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Baseline (randomization), 76 weeks
Change From Baseline in the Resource Utilization in Dementia-Lite (RUD-Lite) up to 76 Weeks
Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation and healthcare resource utilization) was gathered from baseline and follow-up interviews. Reported number of hospitalizations per participant up to 76 weeks. Least Squares (LS) Mean value was controlled for age and investigator.
Baseline (randomization), up to 76 weeks
Change From Baseline in the EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 76 Weeks
EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numerals 1-3 are not added for total score. VAS assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Baseline (randomization), 76 weeks
Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 76 Weeks
Assess QoL for AD: participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items, rated on a 4-point scale. Sum of items=total score (range: 13 to 52). Higher scores indicate greater QoL. Participant's primary caregiver asked to complete same measure. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Baseline (randomization), 76 weeks
Change From Baseline in Mini Mental State Examination (MMSE) at 76 Weeks
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication
Baseline (randomization), 76 weeks
Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks
Concentration of amino acid peptide known as Aβ 1-42 in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Baseline (randomization), 52 weeks
Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks
Measurement of local cerebral glucose metabolism by PET using the radioactive tracer 18F-FDG. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the Pons. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Baseline (randomization), 76 weeks
Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks
The vMRI assessment of right and left hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Baseline (randomization), up to 76 weeks
Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks
A radioactive tracer for PET that is a ligand for amyloid called [18F]-AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Baseline (randomization), up to 76 weeks
Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks
Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Baseline (randomization), up to 76 weeks
LY450139 Population Pharmacokinetics: Clearance of LY450139
Model estimated apparent oral clearance. Clearance is defined as the volume of plasma which is completely cleared of drug (LY450139) per unit time.
6 weeks, 12 weeks, and 52 weeks
LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139
Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which drug distributes in the body.
6 weeks, 12 weeks, and 52 weeks
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 4 Weeks After Cessation of Study Drug
Semi-structured interview. Participant's cognitive status rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, personal care. Severity score assigned for each of 6 domains; total score (SB) ranges: 0 to 18. Higher scores=greater disease severity. Least Squares Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care medication. LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants followed off-dose for 32 weeks, but CDR-SB not assessed.
Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in Neuropsychiatric Inventory (NPI) at 4 Weeks After Cessation of Study Drug
NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with participant's behavior. Total score ranges from 12 to 144; higher scores indicate greater disease severity. The Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but NPI was not assessed.
Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) at 4 Weeks After Cessation of Study Drug
Assesses healthcare resource utilization (formal and informal care). Information gathered on both care-giving time, work status) and participants (accommodation, healthcare resource utilization) is collected. Reported number of participant hospitalizations. Least Squares (LS) Mean value controlled for age and investigator. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but RUD-Lite was not assessed.
Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 4 Weeks After Cessation of Study Drug
EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. VAS assesses caregiver's impression of participant's health state; score ranges: 0 to 100. Lower scores=greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but EQ-5D VAS was not assessed.
Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 4 Weeks After Cessation of Study Drug
Assess QoL for AD; participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL. Participant's primary caregiver asked to complete same measure. Least Squares Mean value controlled for baseline, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but QoL-AD not assessed.
Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in Mini Mental State Examination (MMSE) 4 Weeks After Cessation of Study Drug
Used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges: 0 to 30. Lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but MMSE was not assessed.
Baseline (randomization), 4 weeks following treatment cessation
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 76 Weeks
ADAS-Cog12 is ADAS-Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Baseline (randomization), 76 weeks
Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 76 Weeks
ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Baseline (randomization), 76 weeks
Change From Baseline in Phosphorylated-Tau (P-tau) Concentration in Spinal Fluid up to 76 Weeks
Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Baseline (randomization), up to 76 weeks
Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks
Concentration of an amino acid peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Baseline (randomization), up to 76 weeks
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 16 Weeks After Cessation of Study Drug
ADAS-Cog12 is ADAS-Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Baseline (randomization), 16 weeks following treatment cessation
Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 16 Weeks After Cessation of Study Drug
ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.
Baseline (randomization), 16 weeks following treatment cessation
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Costa Mesa
California
92626
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
La Jolla
California
92037
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Laguna Hills
California
92653
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Angeles
California
90036
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Oxnard
California
93030
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Francisco
California
94109
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Boca Raton
Florida
33431
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hallandale
Florida
33009
United States
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Hollywood
Florida
33021
United States
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Miami
Florida
33137
United States
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Orlando
Florida
32806
United States
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Tampa
Florida
33609
United States
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New Orleans
Louisiana
70131
United States
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Shreveport
Louisiana
71104
United States
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Hattiesburg
Mississippi
39401
United States
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Omaha
Nebraska
68105
United States
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Albany
New York
12205
United States
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Manhasset
New York
11030
United States
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Durham
North Carolina
27710
United States
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Oklahoma City
Oklahoma
73103
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Philadelphia
Pennsylvania
19131
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rio de Janeiro
21020-130
Brazil
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Salvador
40301500
Brazil
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São Paulo
040024-002
Brazil
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Sofia
1527
Bulgaria
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Winnipeg
Manitoba
R3N 0K6
Canada
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Saint John
New Brunswick
E2L 3L6
Canada
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London
Ontario
N6C 5J1
Canada
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ottawa
Ontario
K1N 5C8
Canada
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Peterborough
Ontario
K9H2P4
Canada
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Toronto
Ontario
M3B2S7
Canada
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Greenfield Park
Quebec
J4V 2J2
Canada
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Montreal
Quebec
H1T 2M4
Canada
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Verdun
Quebec
H4H 1R3
Canada
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Beijing
100853
China
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Shanghai
200025
China
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Xi'an
710038
China
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Montpellier
34295
France
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Paris
75651
France
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Poitiers
86021
France
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Strasbourg
67091
France
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Berlin
10629
Germany
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Frankfurt
60528
Germany
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Hamburg
22083
Germany
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Heidelberg
69115
Germany
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Mannheim
68165
Germany
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Budapest
H-1083
Hungary
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Esztergom
2500
Hungary
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Boggiovara
41100
Italy
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Cassino
03043
Italy
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Milan
20122
Italy
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Parma
43100
Italy
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Akita
010-0874
Japan
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Fukuoka
814-0180
Japan
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Hyōgo
655-0037
Japan
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Ibaraki
305-8576
Japan
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Kanagawa
251-0038
Japan
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Kumamoto
861-8002
Japan
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Kyoto
606-0851
Japan
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Nagasaki
852-8108
Japan
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Numakunai
020-8505
Japan
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Osaka
599-8263
Japan
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Saitama
344-0036
Japan
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Tokyo
113-8655
Japan
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Aguascalientes
20217
Mexico
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Monterrey
64710
Mexico
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Saltillo
25000
Mexico
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Bucharest
011241
Romania
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Timișoara
300736
Romania
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Kazan'
420101
Russia
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Saint Petersburg
190021
Russia
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Saratov
410028
Russia
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Yekaterinburg
620030
Russia
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Belgrade
11000
Serbia
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Kragujevac
34000
Serbia
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Seoul
139-707
South Korea
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Suwon
443-721
South Korea
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Changhua
500
Taiwan
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Tainan
70403
Taiwan
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Taipei
111
Taiwan
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Taoyuan
333
Taiwan
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Eskişehir
26480
Turkey (Türkiye)
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Istanbul
34452
Turkey (Türkiye)
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Izmir
35340
Turkey (Türkiye)
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Samsun
Turkey (Türkiye)
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Dnipropetrovsk
49616
Ukraine
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Donetsk
83037
Ukraine
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Kherson
73488
Ukraine
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Kyiv
04080
Ukraine
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Odesa
65006
Ukraine
Henley DB, Dowsett SA, Chen YF, Liu-Seifert H, Grill JD, Doody RS, Aisen P, Raman R, Miller DS, Hake AM, Cummings J. Alzheimer's disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther. 2015 Jun 25;7(1):43. doi: 10.1186/s13195-015-0127-0. eCollection 2015.
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
FG000556 subjects
FG001555 subjects
Intent-to-treat (ITT)
FG000555 subjectsITT population included all randomized participants(pts) who received at least 1 dose of study drug.
FG001553 subjectsITT population included all randomized participants who received at least 1 dose of study drug.
COMPLETED
FG00022 subjects
FG00134 subjects
NOT COMPLETED
FG000534 subjects
FG001521 subjects
Type
Comment
Reasons
Death
FG0007 subjects
FG0016 subjects
Adverse Event
FG000132 subjects
FG00140 subjects
Protocol Violation
FG0004 subjects
FG0011 subjects
Withdrawal by Subject
FG00065 subjects
FG00152 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
Sponsor Decision
FG000293 subjects
FG001401 subjects
Lost to Follow-up
FG0005 subjects
FG0010 subjects
Caregiver Decision
FG00021 subjects
FG00116 subjects
Abnormal Lab/ECG Result
FG0006 subjects
FG0014 subjects
Entry Criteria Exclusion
FG0000 subjects
FG0011 subjects
Delayed Start
Type
Comment
Milestone Data
STARTED
FG00022 subjects
FG00134 subjects
COMPLETED
FG0005 subjects
FG0018 subjects
NOT COMPLETED
FG00017 subjects
FG00126 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0014 subjects
Protocol Violation
FG0000 subjects
FG001
Safety Follow Up (SFU)-Optional
Type
Comment
Milestone Data
STARTED
FG000312 subjectsSFU was optional; pts entered from initial treatment and delayed start or did not enter SFU.
FG001430 subjectsSFU was optional; pts entered from initial treatment and delayed start or did not enter SFU.
COMPLETED
FG000228 subjects
FG001312 subjects
NOT COMPLETED
FG00084 subjects
FG001118 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0018 subjects
Adverse Event
FG0000 subjects
FG001
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
BG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
The cognitive subscale of the ADAS (ADAS-Cog11) consists of 11 items assessing areas of function most typically impaired in AD: orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG00024.5± 9.1
BG001
Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Score (n=505, 529)
The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory developed as a rater-administered questionnaire that should be answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG00058.8± 13.3
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 76 Weeks
The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Units
Counts
Participants
OG000555
OG001553
Title
Denominators
Categories
Title
Measurements
OG0007.37± 0.79
OG0016.77± 0.72
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
0.560
95
No
Superiority or Other
Primary
Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 16 Weeks After Cessation of Study Drug
The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 16 weeks following treatment cessation
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Primary
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 76 Weeks
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Primary
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 16 Weeks After Cessation of Study Drug
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 16 weeks following treatment cessation
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Secondary
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 76 Weeks
CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Secondary
Change From Baseline in Neuropsychiatric Inventory (NPI) at 76 Weeks
NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 12 to 144; higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Units
Counts
Secondary
Change From Baseline in the Resource Utilization in Dementia-Lite (RUD-Lite) up to 76 Weeks
Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation and healthcare resource utilization) was gathered from baseline and follow-up interviews. Reported number of hospitalizations per participant up to 76 weeks. Least Squares (LS) Mean value was controlled for age and investigator.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).
Posted
Least Squares Mean
Standard Error
number of hospitalizations
Baseline (randomization), up to 76 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Secondary
Change From Baseline in the EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 76 Weeks
EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numerals 1-3 are not added for total score. VAS assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Secondary
Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 76 Weeks
Assess QoL for AD: participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items, rated on a 4-point scale. Sum of items=total score (range: 13 to 52). Higher scores indicate greater QoL. Participant's primary caregiver asked to complete same measure. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Units
Secondary
Change From Baseline in Mini Mental State Examination (MMSE) at 76 Weeks
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Units
Counts
Secondary
Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks
Concentration of amino acid peptide known as Aβ 1-42 in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.
Posted
Least Squares Mean
Standard Error
picogram per milliliter (pg/mL)
Baseline (randomization), 52 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Units
Counts
Participants
Secondary
Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks
Measurement of local cerebral glucose metabolism by PET using the radioactive tracer 18F-FDG. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the Pons. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.
Posted
Least Squares Mean
Standard Error
ratio
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Units
Counts
Secondary
Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks
The vMRI assessment of right and left hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).
Posted
Least Squares Mean
Standard Error
cubic millimeter (mm^3)
Baseline (randomization), up to 76 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Units
Counts
Participants
Secondary
Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks
A radioactive tracer for PET that is a ligand for amyloid called [18F]-AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).
Posted
Least Squares Mean
Standard Error
ratio
Baseline (randomization), up to 76 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Units
Counts
Secondary
Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks
Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).
Posted
Least Squares Mean
Standard Error
picogram per milliliter (pg/mL)
Baseline (randomization), up to 76 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Units
Counts
Participants
Secondary
LY450139 Population Pharmacokinetics: Clearance of LY450139
Model estimated apparent oral clearance. Clearance is defined as the volume of plasma which is completely cleared of drug (LY450139) per unit time.
All participants randomized to LY450139 with sufficient dosing information and concentration data to allow estimation of pharmacokinetic parameters.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters per hour (L/h)
6 weeks, 12 weeks, and 52 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Units
Counts
Participants
OG000
Secondary
LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139
Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which drug distributes in the body.
All participants randomized to LY450139 with sufficient dosing information and concentration data to allow estimation of pharmacokinetic parameters.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters (L)
6 weeks, 12 weeks, and 52 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 4 Weeks After Cessation of Study Drug
Semi-structured interview. Participant's cognitive status rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, personal care. Severity score assigned for each of 6 domains; total score (SB) ranges: 0 to 18. Higher scores=greater disease severity. Least Squares Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care medication. LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants followed off-dose for 32 weeks, but CDR-SB not assessed.
August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.
Posted
Baseline (randomization), 4 weeks following treatment cessation
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Secondary
Change From Baseline in Neuropsychiatric Inventory (NPI) at 4 Weeks After Cessation of Study Drug
NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with participant's behavior. Total score ranges from 12 to 144; higher scores indicate greater disease severity. The Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but NPI was not assessed.
August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.
Posted
Baseline (randomization), 4 weeks following treatment cessation
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Secondary
Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) at 4 Weeks After Cessation of Study Drug
Assesses healthcare resource utilization (formal and informal care). Information gathered on both care-giving time, work status) and participants (accommodation, healthcare resource utilization) is collected. Reported number of participant hospitalizations. Least Squares (LS) Mean value controlled for age and investigator. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but RUD-Lite was not assessed.
August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.
Posted
Baseline (randomization), 4 weeks following treatment cessation
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Secondary
Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 4 Weeks After Cessation of Study Drug
EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. VAS assesses caregiver's impression of participant's health state; score ranges: 0 to 100. Lower scores=greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but EQ-5D VAS was not assessed.
August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.
Posted
Baseline (randomization), 4 weeks following treatment cessation
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Secondary
Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 4 Weeks After Cessation of Study Drug
Assess QoL for AD; participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL. Participant's primary caregiver asked to complete same measure. Least Squares Mean value controlled for baseline, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but QoL-AD not assessed.
August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.
Posted
Baseline (randomization), 4 weeks following treatment cessation
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Secondary
Change From Baseline in Mini Mental State Examination (MMSE) 4 Weeks After Cessation of Study Drug
Used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges: 0 to 30. Lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but MMSE was not assessed.
August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.
Posted
Baseline (randomization), 4 weeks following treatment cessation
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Secondary
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 76 Weeks
ADAS-Cog12 is ADAS-Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Units
Counts
Secondary
Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 76 Weeks
ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Secondary
Change From Baseline in Phosphorylated-Tau (P-tau) Concentration in Spinal Fluid up to 76 Weeks
Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).
Posted
Least Squares Mean
Standard Error
picogram per milliliter (pg/mL)
Baseline (randomization), up to 76 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Units
Counts
Participants
Secondary
Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks
Concentration of an amino acid peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).
Posted
Least Squares Mean
Standard Error
picogram per milliliter (pg/mL)
Baseline (randomization), up to 76 weeks
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Units
Counts
Participants
Secondary
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 16 Weeks After Cessation of Study Drug
ADAS-Cog12 is ADAS-Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 16 weeks following treatment cessation
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Units
Secondary
Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 16 Weeks After Cessation of Study Drug
ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.
Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 16 weeks following treatment cessation
ID
Title
Description
OG000
140 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
OG001
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo- (Initial Treatment Period [NT])
Participants received placebo orally once daily for the first 76 weeks.
60
555
130
555
EG001
140 mg LY450139- NT
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 76.
92
556
258
556
EG002
Placebo- (Delayed Start Period [DO])
After Week 76, participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
7
34
6
34
EG003
140 mg LY450139- DO
After Week 76, participants received 140 mg LY450139 orally once daily until Week 88.
1
22
0
22
EG004
Placebo-Safety Follow Up Period (SFU)
For SFU, study drug had been stopped and period was optional to enter; Participants entered from Placebo initial treatment or delayed start or did not enter SFU.
22
430
0
430
EG005
140 mg LY450139 - SFU
For SFU, study drug had been stopped and period was optional to enter; Participants entered from 140 mg LY450139 initial treatment or delayed start or did not enter SFU.
20
312
0
312
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia folate deficiency
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG0030 events0 affected22 at risk
EG004
Angina pectoris
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Aortic valve stenosis
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0012 events2 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Cataract
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Retinal artery occlusion
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0012 events2 affected556 at risk
EG0021 events1 affected34 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0021 events1 affected34 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0021 events1 affected34 at risk
EG003
Accidental death
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Chest pain
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Death
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Sudden cardiac death
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0012 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Cholecystitis chronic
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0012 events2 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Hepatitis toxic
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0012 events2 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0012 events2 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Clostridial infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Cystitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Diabetic gangrene
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0012 events2 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Meningitis bacterial
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected555 at risk
EG00113 events12 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Pneumonia staphylococcal
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Salmonella sepsis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Sepsis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Septic shock
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0003 events3 affected555 at risk
EG0014 events4 affected556 at risk
EG0021 events1 affected34 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0003 events3 affected555 at risk
EG0013 events3 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0003 events2 affected555 at risk
EG0012 events2 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0012 events2 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Fractured sacrum
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Heat exhaustion
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0012 events2 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Post lumbar puncture syndrome
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0012 events2 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Blood glucose increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Medical observation
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected555 at risk
EG0013 events3 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Food intolerance
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0021 events1 affected34 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0021 events1 affected34 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Osteitis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Bile duct cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Breast cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0013 events3 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Endometrial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected328 at risk
EG0010 events0 affected317 at risk
EG0020 events0 affected20 at risk
EG003
Hepatic cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Keratoacanthoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Neurilemmoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Neuroendocrine carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0013 events3 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected555 at risk
EG0012 events2 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Coma
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0013 events3 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Dementia alzheimer's type
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected555 at risk
EG0012 events2 affected556 at risk
EG0021 events1 affected34 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Guillain-barre syndrome
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Normal pressure hydrocephalus
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Status epilepticus
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Syncope
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0004 events4 affected555 at risk
EG0015 events5 affected556 at risk
EG0021 events1 affected34 at risk
EG003
Thalamus haemorrhage
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Aggression
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0012 events2 affected556 at risk
EG0021 events1 affected34 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0012 events2 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Urethral caruncle
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected227 at risk
EG0011 events1 affected239 at risk
EG0020 events0 affected14 at risk
EG003
Choking
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0021 events1 affected34 at risk
EG003
Activities of daily living impaired
Social circumstances
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Arteriosclerosis obliterans
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0011 events1 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Haematoma
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Hypertension
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected555 at risk
EG0010 events0 affected556 at risk
EG0021 events1 affected34 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG00042 events33 affected555 at risk
EG00172 events58 affected556 at risk
EG0020 events0 affected34 at risk
EG0030 events0 affected22 at risk
EG0040 events0 affected430 at risk
EG0050 events0 affected312 at risk
Hiatus hernia
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0022 events2 affected34 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG00024 events19 affected555 at risk
EG00153 events49 affected556 at risk
EG0022 events2 affected34 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG00022 events17 affected555 at risk
EG00146 events33 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG00024 events22 affected555 at risk
EG00131 events28 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected555 at risk
EG0010 events0 affected556 at risk
EG0023 events3 affected34 at risk
EG003
Prostatic specific antigen increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected227 at risk
EG0010 events0 affected239 at risk
EG0021 events1 affected14 at risk
EG003
Weight decreased
Investigations
MedDRA 13.1
Systematic Assessment
EG00016 events16 affected555 at risk
EG00142 events42 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG00016 events16 affected555 at risk
EG00153 events52 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG00015 events15 affected555 at risk
EG00132 events30 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG00029 events24 affected555 at risk
EG00145 events40 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Hair colour changes
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0004 events4 affected555 at risk
EG00153 events53 affected556 at risk
EG0020 events0 affected34 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0006 events5 affected555 at risk
EG00142 events36 affected556 at risk
EG0020 events0 affected34 at risk
EG003
All dosing for 4-week post-study drug cessation timeframe outcome measures stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening for LY450139 participants. No assessments made during 32-week follow up.