Effect of LY450139 on the Long Term Progression of Alzhei... | NCT00594568 | Trialant
NCT00594568
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Mar 17, 2015Estimated
Enrollment
1,537Actual
Phase
Phase 3
Conditions
Alzheimer's Disease
Interventions
LY450139
Placebo
Countries
United States
Argentina
Australia
Belgium
Canada
Chile
Denmark
Finland
France
Germany
India
Israel
Italy
Japan
Poland
South Africa
Spain
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00594568
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
7666
Secondary IDs
ID
Type
Description
Link
H6L-MC-LFAN
Other Identifier
Eli Lilly and Company
CTRI/2009/091/000090
Registry Identifier
India
Brief Title
Effect of LY450139 on the Long Term Progression of Alzheimer's Disease
Official Title
Effect of γ-Secretase Inhibition on the Progression of Alzheimer's Disease: LY450139 Versus Placebo
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Mar 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
Mar 2008
Primary Completion Date
May 2011Actual
Completion Date
May 2011Actual
First Submitted Date
Jan 11, 2008
First Submission Date that Met QC Criteria
Jan 11, 2008
First Posted Date
Jan 15, 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 9, 2011
Certification/Extension First Submitted that Passed QC Review
Aug 9, 2011
Certification/Extension First Posted Date
Aug 15, 2011Estimated
Last Update Submitted Date
Mar 13, 2015
Last Update Posted Date
Mar 17, 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 participants. The build-up 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 participants. In this trial, participants 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 participants could eventually receive active drug. Participation could last approximately 2 years. Participants taking approved AD medications were permitted to participate in this study and continue taking these medications during the study. All participants who completed this study had the option to continue receiving semagacestat by participating in an open-label study.
Preliminary results from this study (H6L-MC-LFAN [LFAN]) and another similar study (H6L-MC-LFBC [LFBC; NCT00762411]) 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. Studies LFAN, LFBC, and open-label H6L-MC-LFBF (LFBF; NCT01035138) were amended to continue collecting safety data, including cognitive scores, for at least 7 months. The Clinical Trial Registry (CTR) will reflect results of analyses from the original LFAN protocol in addition to those from the amended LFAN protocol.
Detailed Description
Not provided
Conditions Module
Conditions
Alzheimer's Disease
Keywords
Not provided
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
1,537Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 milligrams (mg) orally once daily until Week 88.
Drug: Placebo
100 mg LY450139
Experimental
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
Drug: LY450139
140 mg LY450139
Experimental
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.
Drug: LY450139
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY450139
Drug
Administered orally once daily
100 mg LY450139
140 mg LY450139
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 76 Weeks
ADAS-Cog11 was used as a primary efficacy measure. It 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) Score at 16 Weeks After Cessation of Study Drug
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 (ADCS-ADL) Inventory Score at 76 Weeks
ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of 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 (ADCS-ADL) Inventory Score at 16 Weeks After Cessation of Study Drug
ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of 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.
Secondary Outcomes
Measure
Description
Time Frame
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
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 (MMSE) score of 16-26 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 at 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 or drug abuse within the past 5 years
Has ever had 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 placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
Baseline (randomization), 16 weeks following treatment cessation
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 left and right 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 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 that 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 the drug distributes in the body.
6 weeks, 12 weeks, and 52 weeks
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score 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-Cognitive Subscale (ADAS-Cog14) Score 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, concomitant standard of care (SOC) medication.
Baseline (randomization), 76 weeks
Change From Baseline in Mini Mental State Examination (MMSE) Score at 76 Weeks
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures) in elderly participants. The 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
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score 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.
Baseline (randomization), 76 weeks
Change From Baseline in Neuropsychiatric Inventory (NPI) Score 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 EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score 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 from 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 Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) up to 76 Weeks
Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) was collected 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 Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score 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-Cognitive Subscale (ADAS-Cog14) Score 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
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score 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. LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) 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) Score 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. 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 Mini Mental State Examination (MMSE) Score at 4 Weeks After Cessation of Study Drug
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, copy figures) in elderly participants. Total score ranges from 0 to 30; Lower score indicates greater disease severity. 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 EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score 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 from 0 to 100; Lower score indicates greater disease severity. 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 Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) at 4 Weeks After Cessation of Study Drug
RUD-Lite assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (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 Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks
Concentration of an amino 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 Phosphorylated-Tau (P-Tau) Concentration in Spinal Fluid
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
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.
Phoenix
Arizona
85006
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.
Sun City
Arizona
85351
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.
Tucson
Arizona
85741
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.
Fresno
California
93720
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.
Lomita
California
90717
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.
Orange
California
92868
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.
Sacramento
California
95817
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 Diego
California
92103
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.
Santa Monica
California
90404
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.
Hamden
Connecticut
06518
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.
New Haven
Connecticut
06510
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.
Washington D.C.
District of Columbia
20057
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.
Brooksville
Florida
34613
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.
Fort Lauderdale
Florida
33308
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.
Fort Myers
Florida
33912
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.
Miami
Florida
33140
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.
Pompano Beach
Florida
33064
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.
St. Petersburg
Florida
33716
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.
Sunrise
Florida
33351
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.
Tampa
Florida
33613
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.
Tampa Bay
Florida
33613
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.
West Palm Beach
Florida
33407
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.
Chicago
Illinois
60611
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.
Indianapolis
Indiana
46202
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.
Lexington
Kentucky
40503
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.
Shreveport
Louisiana
71101
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.
Baltimore
Maryland
21224
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.
Boston
Massachusetts
02118
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.
Burlington
Massachusetts
01805
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.
West Yarmouth
Massachusetts
02673
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.
Kansas City
Missouri
64111
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.
St Louis
Missouri
63108
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.
Albany
New York
12208
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.
New York
New York
10032
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.
Durham
North Carolina
27705
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.
Raleigh
North Carolina
27607
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.
Winston-Salem
North Carolina
27157
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.
Columbus
Ohio
43210
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.
Toledo
Ohio
43623
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.
Oklahoma City
Oklahoma
73116
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.
Eugene
Oregon
97401
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.
Jenkintown
Pennsylvania
19046
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
19104
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.
Pittsburgh
Pennsylvania
15213
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.
East Providence
Rhode Island
02914
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.
North Charleston
South Carolina
29406
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.
Salt Lake City
Utah
84108
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.
Bennington
Vermont
05201
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.
Madison
Wisconsin
53705
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.
Buenos Aires
1425
Argentina
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.
Córdoba
X5004AOA
Argentina
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.
Santa Fe
S3000FWO
Argentina
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.
Hornsby
New South Wales
2077
Australia
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.
Kogarah
New South Wales
2217
Australia
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.
Randwick, Sydney
New South Wales
2013
Australia
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.
Adelaide
South Australia
5000
Australia
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.
Geelong
Victoria
3220
Australia
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.
Heidelberg West
Victoria
3081
Australia
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.
Kew
Victoria
3101
Australia
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.
Nedlands
Western Australia
6009
Australia
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.
Aalst
9300
Belgium
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.
Antwerp
2020
Belgium
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.
Bruges
8000
Belgium
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.
Leuven
3000
Belgium
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.
Kelowna
British Columbia
V1Y3G8
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.
Penticton
British Columbia
V2A5C8
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.
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.
Sherbrooke
Quebec
J1H1Z1
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.
Antofagasta
Chile
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.
Concepción
Chile
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.
Santiago
6640870
Chile
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.
Santiago
Chile
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.
Valdivia
Chile
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.
Viña del Mar
Chile
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.
Copenhagen
2100
Denmark
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.
Roskilde
4000
Denmark
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.
Svendborg
4000
Denmark
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.
Kuopio
70210
Finland
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.
Mikkeli
50100
Finland
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.
Oulu
90229
Finland
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.
Nice
06002
France
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.
Rennes
35000
France
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.
Rouen
76036
France
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.
Toulouse
31059
France
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.
Tours
37044
France
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.
Dresden
01307
Germany
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.
Göttingen
37075
Germany
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.
Hanover
30559
Germany
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.
München
BY 80336
Germany
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.
Regensburg
D-93053
Germany
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.
Siegen
57072
Germany
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.
Chennai
600003
India
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.
Hyderabaad
400082
India
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.
Kolkata
700054
India
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.
Mangalore
575002
India
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.
Mumbai
400050
India
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.
Thiruvananthapuram
695011
India
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.
Tirupati
517507
India
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.
Varanasi
221005
India
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.
Ashkelon
78306
Israel
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.
Beersheba
84170
Israel
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.
Haifa
31096
Israel
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.
Jerusalem
91240
Israel
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.
Petah Tikva
49100
Israel
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.
Tel Aviv
64239
Israel
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.
Tel Litwinsky
52661
Israel
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.
Milan
20157
Italy
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.
Pisa
56126
Italy
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.
Rome
00153
Italy
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.
Fukui
910-3113
Japan
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.
Fukuoka
770-8076
Japan
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.
Kagawa
761-0793
Japan
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.
Kochi
780-0842
Japan
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.
Osaka
590-0018
Japan
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.
Tokushima
770-8076
Japan
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.
Bialystok
15402
Poland
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.
Gdynia
81-361
Poland
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.
Lodz
92-216
Poland
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.
Lublin
20-950
Poland
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.
Poznan
61-606
Poland
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.
Warsaw
02-507
Poland
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.
Bellair
4094
South Africa
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.
Bellville
7530
South Africa
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.
Cape Town
7925
South Africa
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.
George
6529
South Africa
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.
Johannesburg
1709
South Africa
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.
Rosebank
2132
South Africa
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.
Somerset West
7130
South Africa
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.
Umhlanga
4319
South Africa
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.
Albacete
2006
Spain
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.
Barakaldo
48903
Spain
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.
Barcelona
08014
Spain
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.
Madrid
28034
Spain
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.
Plasencia
10600
Spain
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.
Malmö
20502
Sweden
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.
Mölndal
43185
Sweden
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.
Norrköping
60172
Sweden
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.
Stockholm
14186
Sweden
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.
Uddevalla
45180
Sweden
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.
Bath
Banes
BA1 3NG
United Kingdom
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.
Southampton
Hants
SO30 3JB
United Kingdom
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.
Liverpool
Merseyside
L9 7LJ
United Kingdom
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.
Glasgow
Scotland
G20 0XA
United Kingdom
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.
Swindon
Wilts
SN1 4JU
United Kingdom
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.
Belfast
BT9 7BL
United Kingdom
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.
Newcastle
NE4 6BE
United Kingdom
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.
Stoke-on-Trent
ST4 6QG
United Kingdom
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.
Doody RS, Raman R, Sperling RA, Seimers E, Sethuraman G, Mohs R, Farlow M, Iwatsubo T, Vellas B, Sun X, Ernstrom K, Thomas RG, Aisen PS; Alzheimer's Disease Cooperative Study. Peripheral and central effects of gamma-secretase inhibition by semagacestat in Alzheimer's disease. Alzheimers Res Ther. 2015 Jun 10;7(1):36. doi: 10.1186/s13195-015-0121-6. eCollection 2015.
Doody RS, Raman R, Farlow M, Iwatsubo T, Vellas B, Joffe S, Kieburtz K, He F, Sun X, Thomas RG, Aisen PS; Alzheimer's Disease Cooperative Study Steering Committee; Siemers E, Sethuraman G, Mohs R; Semagacestat Study Group. A phase 3 trial of semagacestat for treatment of Alzheimer's disease. N Engl J Med. 2013 Jul 25;369(4):341-50. doi: 10.1056/NEJMoa1210951.
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
FG002
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.
FG000501 subjects
FG001507 subjects
FG002529 subjects
Intent-to-treat (ITT)
FG000501 subjectsITT population included all randomized participants (pts) who had at least 1 dose of study drug.
FG001506 subjectsITT population included all randomized participants who had at least 1 dose of study drug.
FG002527 subjectsITT population included all randomized participants who had at least 1 dose of study drug.
COMPLETED
FG000189 subjects
FG001153 subjects
FG002121 subjects
NOT COMPLETED
FG000312 subjects
FG001354 subjects
FG002408 subjects
Type
Comment
Reasons
Adverse Event
FG00051 subjects
FG001121 subjects
FG002144 subjects
Death
FG0006 subjects
FG00111 subjects
FG00215 subjects
Lost to Follow-up
FG0004 subjects
FG0011 subjects
FG0024 subjects
Physician Decision
FG0003 subjects
FG0012 subjects
FG0024 subjects
Protocol Violation
FG0002 subjects
FG0012 subjects
FG0025 subjects
Withdrawal by Subject
FG00025 subjects
FG00131 subjects
FG00246 subjects
Sponsor decision
FG000193 subjects
FG001142 subjects
FG002147 subjects
Caregiver decision
FG00021 subjects
FG00136 subjects
FG00236 subjects
Abnormal lab/electrocardiogram (ECG)
FG0007 subjects
FG0017 subjects
FG0026 subjects
Entry criteria exclusion
FG0000 subjects
FG0011 subjects
FG0021 subjects
Delayed Start
Type
Comment
Milestone Data
STARTED
FG000189 subjects
FG001153 subjects
FG002121 subjects
COMPLETED
FG00091 subjects
FG00176 subjects
FG00255 subjects
NOT COMPLETED
FG00098 subjects
FG00177 subjects
FG00266 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
Adverse Event
FG000
Safety Follow Up (SFU)-Optional
Type
Comment
Milestone Data
STARTED
FG000290 subjectsSFU was optional; pts entered from initial treatment and delayed start or did not enter SFU.
FG001223 subjectsSFU was optional; pts entered from initial treatment and delayed start or did not enter SFU.
FG002214 subjectsSFU was optional, pts entered from initial treatment and delayed start or did not enter SFU.
COMPLETED
FG000229 subjects
FG001168 subjects
FG002172 subjects
NOT COMPLETED
FG00061 subjects
FG00155 subjects
FG00242 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
Adverse Event
FG000
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
BG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
BG002
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.
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
BG00022.8± 9.1
BG001
Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score
The ADCS-ADL Inventory Score is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of 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
BG00060.5± 13.0
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) Score at 76 Weeks
ADAS-Cog11 was used as a primary efficacy measure. It 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.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
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
OG000270
OG001216
OG002199
Title
Denominators
Categories
Title
Measurements
OG0006.19± 0.54
OG0017.29± 0.57
OG0027.68± 0.59
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
0.134
95
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.045
Primary
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 16 Weeks After Cessation of Study Drug
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.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 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
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
140 mg LY450139
Primary
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 76 Weeks
ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of 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.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
140 mg LY450139
Primary
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 16 Weeks After Cessation of Study Drug
ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of 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.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 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
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
140 mg LY450139
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.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.
Posted
Least Squares Mean
Standard Error
picogram per milliliter (pg/mL)
Baseline (randomization), 52 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
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.
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.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.
Posted
Least Squares Mean
Standard Error
ratio
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
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.
Secondary
Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks
The vMRI assessment of left and right hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.
Posted
Least Squares Mean
Standard Error
cubic millimeter (mm^3)
Baseline (randomization), up to 76 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
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.
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 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.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.
Posted
Least Squares Mean
Standard Error
ratio
Baseline (randomization), up to 76 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
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.
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.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.
Posted
Least Squares Mean
Standard Error
picogram per milliliter (pg/mL)
Baseline (randomization), up to 76 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
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.
Secondary
LY450139 Population Pharmacokinetics: Clearance of LY450139
Model estimated apparent oral clearance. Clearance is defined as the volume of plasma that is completely cleared of drug (LY450139) per unit time.
The analysis population (N=974) included all participants randomized to LY450139 with sufficient drug concentration and dosing information to allow estimation of clearance.
Posted
Geometric Mean
Geometric Coefficient of Variation
liter per hour (L/h)
6 weeks, 12 weeks, and 52 weeks
ID
Title
Description
OG000
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 the drug distributes in the body.
The analysis population (N=974) included all participants randomized to LY450139 with sufficient drug concentration and dosing information to allow estimation of volume of distribution.
Posted
Geometric Mean
Geometric Coefficient of Variation
liter (L)
6 weeks, 12 weeks, and 52 weeks
ID
Title
Description
OG000
LY450139
Participants received 60 milligram 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 Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score 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.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
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.
Secondary
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score 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, concomitant standard of care (SOC) medication.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
140 mg LY450139
Secondary
Change From Baseline in Mini Mental State Examination (MMSE) Score at 76 Weeks
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures) in elderly participants. The 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.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
140 mg LY450139
Secondary
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score 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.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
140 mg LY450139
Secondary
Change From Baseline in Neuropsychiatric Inventory (NPI) Score 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.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
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.
Secondary
Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score 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 from 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.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (randomization), 76 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
Secondary
Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) up to 76 Weeks
Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) was collected 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.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.
Posted
Least Squares Mean
Standard Error
hospitalizations/participant
Baseline (randomization), up to 76 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
140 mg LY450139
Secondary
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score 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.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 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
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
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.
Secondary
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score 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.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 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
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
Secondary
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score 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. LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) 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
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
Secondary
Change From Baseline in Neuropsychiatric Inventory (NPI) Score 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. 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
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
Secondary
Change From Baseline in Mini Mental State Examination (MMSE) Score at 4 Weeks After Cessation of Study Drug
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, copy figures) in elderly participants. Total score ranges from 0 to 30; Lower score indicates greater disease severity. 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
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 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) Score 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 from 0 to 100; Lower score indicates greater disease severity. 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
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
Secondary
Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) at 4 Weeks After Cessation of Study Drug
RUD-Lite assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (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
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
Secondary
Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks
Concentration of an amino peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.
Posted
Least Squares Mean
Standard Error
picogram per milliliter (pg/mL)
Baseline (randomization), up to 76 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
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.
Secondary
Change From Baseline in Phosphorylated-Tau (P-Tau) Concentration in Spinal Fluid
Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.
The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.
Posted
Least Squares Mean
Standard Error
picogram per milliliter (pg/mL)
Baseline (randomization), up to 76 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
OG001
100 mg LY450139
Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
OG002
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.
Time Frame
Not provided
Description
Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
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. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 milligrams (mg) orally once daily until Week 88.
72
501
262
501
EG001
100 mg LY450139 - NT
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.
123
507
310
507
EG002
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 88.
132
529
385
529
EG003
Placebo - Delayed Start Period (DO)
Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
10
192
0
192
EG004
100 mg LY450139 - DO
Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.
9
153
0
153
EG005
140 mg LY450139 - DO
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.
5
124
0
124
EG006
Placebo- Safety FU 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.
12
290
0
290
EG007
100 mg LY450139- SFU
For SFU, study drug had been stopped and period was optional to enter; Participants entered from 100 mg LY450139 initial treatment or delayed start or did not enter SFU.
22
223
0
223
EG008
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.
5
214
0
214
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG0030 events0 affected192 at risk
EG0040 events0 affected153 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected290 at risk
EG0070 events0 affected223 at risk
EG0080 events0 affected214 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Aortic valve incompetence
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0003 events3 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0013 events3 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0023 events2 affected529 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Nodal rhythm
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Pleuropericarditis
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Sick sinus syndrome
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0011 events1 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Torsade de pointes
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Cataract
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0003 events2 affected501 at risk
EG0012 events2 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Glaucoma
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0012 events2 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0011 events1 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0023 events2 affected529 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Inflammatory bowel disease
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0022 events2 affected529 at risk
EG003
Inguinal hernia strangulated
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Inguinal hernia, obstructive
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0012 events2 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Oesophageal rupture
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0022 events2 affected529 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Pancreatitis necrotising
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Volvulus
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0013 events2 affected507 at risk
EG0022 events2 affected529 at risk
EG003
Asthenia
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0011 events1 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Chest pain
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Death
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Device dislocation
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Gait disturbance
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 13.1
Systematic Assessment
EG0003 events3 affected501 at risk
EG0013 events3 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Oedema peripheral
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Sudden death
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0002 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Gallbladder disorder
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Abscess oral
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0012 events2 affected507 at risk
EG0023 events3 affected529 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0012 events2 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Campylobacter gastroenteritis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Candidiasis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0012 events2 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Cholecystitis infective
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Clostridial infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Cystitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Device related infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Epiglottitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Gastric infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0012 events2 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Necrotising fasciitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0022 events2 affected529 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0012 events2 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0006 events6 affected501 at risk
EG00114 events14 affected507 at risk
EG0028 events6 affected529 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Pneumonia haemophilus
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Pneumonia legionella
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Pseudomembranous colitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0022 events2 affected529 at risk
EG003
Pyometra
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected278 at risk
EG0010 events0 affected280 at risk
EG0021 events1 affected263 at risk
EG003
Renal cyst infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Salmonellosis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Sepsis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0012 events2 affected507 at risk
EG0022 events2 affected529 at risk
EG003
Septic shock
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Sinobronchitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0012 events2 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0003 events3 affected501 at risk
EG0014 events4 affected507 at risk
EG0025 events5 affected529 at risk
EG003
Urinary tract infection pseudomonal
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0022 events2 affected529 at risk
EG003
Viral infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Wound infection staphylococcal
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0005 events5 affected501 at risk
EG0014 events4 affected507 at risk
EG0027 events7 affected529 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0003 events3 affected501 at risk
EG0012 events2 affected507 at risk
EG0023 events3 affected529 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0011 events1 affected507 at risk
EG0024 events3 affected529 at risk
EG003
Fractured sacrum
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0011 events1 affected507 at risk
EG0023 events3 affected529 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Meniscus lesion
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Pubis fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0012 events2 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0011 events1 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0022 events2 affected529 at risk
EG003
Sternal fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Weight decreased
Investigations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0012 events2 affected507 at risk
EG0025 events5 affected529 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0012 events2 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Starvation
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Muscle atrophy
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected501 at risk
EG0014 events4 affected507 at risk
EG0023 events3 affected529 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Anal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0022 events2 affected529 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0011 events1 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Breast cancer stage iv
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Colon cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Colon neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Gastrointestinal tract adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Gingival cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Keratoacanthoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0014 events4 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Lung squamous cell carcinoma stage i
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Lung squamous cell carcinoma stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Mesothelioma malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Metastases to liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Non-hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Ovarian fibroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected278 at risk
EG0011 events1 affected280 at risk
EG0020 events0 affected263 at risk
EG003
Pancreatic carcinoma stage iv
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected223 at risk
EG0010 events0 affected227 at risk
EG0021 events1 affected266 at risk
EG003
Prostate cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected223 at risk
EG0010 events0 affected227 at risk
EG0021 events1 affected266 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0013 events3 affected507 at risk
EG0025 events4 affected529 at risk
EG003
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected278 at risk
EG0010 events0 affected280 at risk
EG0020 events0 affected263 at risk
EG003
Vaginal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected278 at risk
EG0011 events1 affected280 at risk
EG0020 events0 affected263 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Brain stem stroke
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Cerebellar haemorrhage
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0012 events2 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Dementia alzheimer's type
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0003 events3 affected501 at risk
EG0011 events1 affected507 at risk
EG0023 events3 affected529 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0022 events2 affected529 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0022 events2 affected529 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Grand mal convulsion
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0012 events2 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Hypertensive encephalopathy
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Ischaemic cerebral infarction
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0024 events4 affected529 at risk
EG003
Migraine
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Normal pressure hydrocephalus
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0023 events3 affected529 at risk
EG003
Psychomotor skills impaired
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Syncope
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected501 at risk
EG0017 events7 affected507 at risk
EG0026 events6 affected529 at risk
EG003
Thalamus haemorrhage
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0011 events1 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Abnormal behaviour
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Aggression
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected501 at risk
EG0011 events1 affected507 at risk
EG0022 events2 affected529 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0013 events3 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Behavioural and psychiatric symptoms of dementia
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Delusion
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Delusional disorder, unspecified type
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Depression
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Hallucination, visual
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Hypomania
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Mental disorder
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Paranoia
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Bladder disorder
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Bladder neck obstruction
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Cystitis glandularis
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Eosinophilic cystitis
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0022 events2 affected529 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0012 events2 affected507 at risk
EG0022 events2 affected529 at risk
EG003
Renal injury
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Urethral caruncle
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Urethral stenosis
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected223 at risk
EG0012 events2 affected227 at risk
EG0021 events1 affected266 at risk
EG003
Prostatic obstruction
Reproductive system and breast disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected223 at risk
EG0010 events0 affected227 at risk
EG0021 events1 affected266 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0012 events2 affected507 at risk
EG0022 events2 affected529 at risk
EG003
Asphyxia
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0023 events2 affected529 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Hydropneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0022 events2 affected529 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Pemphigoid
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0012 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Immobile
Social circumstances
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Aortic aneurysm rupture
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0021 events1 affected529 at risk
EG003
Embolism venous
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Hypertension
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Hypotension
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected507 at risk
EG0022 events2 affected529 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Varicose vein
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Venous insufficiency
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected507 at risk
EG0020 events0 affected529 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG00093 events54 affected501 at risk
EG00167 events54 affected507 at risk
EG00287 events71 affected529 at risk
EG0030 events0 affected192 at risk
EG0040 events0 affected153 at risk
EG0050 events0 affected124 at risk
EG0060 events0 affected290 at risk
EG0070 events0 affected223 at risk
EG0080 events0 affected214 at risk
Nausea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG00027 events23 affected501 at risk
EG00169 events51 affected507 at risk
EG00271 events63 affected529 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG00021 events18 affected501 at risk
EG00150 events44 affected507 at risk
EG00267 events44 affected529 at risk
EG003
Fatigue
General disorders
MedDRA 13.1
Systematic Assessment
EG00032 events30 affected501 at risk
EG00125 events24 affected507 at risk
EG00236 events31 affected529 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG00040 events33 affected501 at risk
EG00126 events24 affected507 at risk
EG00233 events31 affected529 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG00020 events19 affected501 at risk
EG00133 events27 affected507 at risk
EG00239 events31 affected529 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG00039 events29 affected501 at risk
EG00144 events31 affected507 at risk
EG00244 events39 affected529 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG00050 events40 affected501 at risk
EG00145 events36 affected507 at risk
EG00237 events33 affected529 at risk
EG003
Weight decreased
Investigations
MedDRA 13.1
Systematic Assessment
EG00014 events13 affected501 at risk
EG00125 events25 affected507 at risk
EG00248 events47 affected529 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG00016 events16 affected501 at risk
EG00137 events36 affected507 at risk
EG00261 events56 affected529 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG00021 events21 affected501 at risk
EG00141 events32 affected507 at risk
EG00230 events28 affected529 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG00046 events35 affected501 at risk
EG00142 events33 affected507 at risk
EG00257 events41 affected529 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG00023 events22 affected501 at risk
EG00127 events27 affected507 at risk
EG00227 events25 affected529 at risk
EG003
Depression
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG00015 events15 affected501 at risk
EG00123 events23 affected507 at risk
EG00236 events35 affected529 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG00021 events19 affected501 at risk
EG00128 events26 affected507 at risk
EG00222 events22 affected529 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG00022 events19 affected501 at risk
EG00136 events29 affected507 at risk
EG00236 events35 affected529 at risk
EG003
Hair colour changes
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0008 events7 affected501 at risk
EG00164 events63 affected507 at risk
EG002106 events99 affected529 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG00010 events9 affected501 at risk
EG00125 events23 affected507 at risk
EG00238 events28 affected529 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG00020 events17 affected501 at risk
EG00143 events36 affected507 at risk
EG00250 events43 affected529 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0008 events7 affected501 at risk
EG00117 events16 affected507 at risk
EG00228 events27 affected529 at risk
EG003
Outcomes with 4-week after study drug cessation timeframe=All dosing stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening for LY450139 participants; followed for 32 weeks; not all assessments were made.
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
OG000204
OG001154
OG002146
Title
Denominators
Categories
Title
Measurements
OG0006.59± 0.80
OG0017.57± 0.91
OG0027.90± 0.90
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
0.296
95
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.172
95
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.746
95
No
Superiority or Other
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
OG000266
OG001216
OG002197
Title
Denominators
Categories
Title
Measurements
OG000-8.76± 0.72
OG001-10.13± 0.77
OG002-12.70± 0.79
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
0.166
95
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
<0.001
95
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.014
95
No
Superiority or Other
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
OG000198
OG001153
OG002147
Title
Denominators
Categories
Title
Measurements
OG000-9.26± 1.14
OG001-9.15± 1.28
OG002-11.73± 1.26
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
0.935
95
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.068
95
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.070
95
No
Superiority or Other
Units
Counts
Participants
OG000309
OG001265
OG002245
Title
Denominators
Categories
Title
Measurements
OG0003.86± 2.32
OG001-5.97± 2.50
OG002-19.95± 2.58
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
ANCOVA
0.002
95
No
Superiority or Other
OG000
OG002
ANCOVA
<0.001
95
No
Superiority or Other
OG001
OG002
ANCOVA
<0.001
95
No
Superiority or Other
Units
Counts
Participants
OG00040
OG00142
OG00243
Title
Denominators
Categories
Title
Measurements
OG000-0.08± 0.01
OG001-0.12± 0.01
OG002-0.11± 0.02
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
ANCOVA
0.038
95
No
Superiority or Other
OG000
OG002
ANCOVA
0.147
95
No
Superiority or Other
OG001
OG002
ANCOVA
0.604
95
No
Superiority or Other
Units
Counts
Participants
OG00075
OG00169
OG00264
Title
Denominators
Categories
Left Hippocampal Volume
Title
Measurements
OG000-96.54± 10.73
OG001-75.34± 11.06
OG002-107.62± 11.38
Right Hippocampal Volume
Title
Measurements
OG000-108.69± 11.56
OG001-93.89± 12.19
OG002-112.40± 12.52
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
ANCOVA
0.143
This is the p-value for the Left Hippocampal Volume
95
No
Superiority or Other
OG000
OG002
ANCOVA
0.464
This is the p-value for the Left Hippocampal Volume
95
No
Superiority or Other
OG001
OG002
ANCOVA
0.025
This is the p-value for the Left Hippocampal Volume
95
No
Superiority or Other
OG000
OG001
ANCOVA
0.347
This is the p-value for the Right Hippocampal Volume
95
No
Superiority or Other
OG000
OG002
ANCOVA
0.820
This is the p-value for the Right Hippocampal Volume
95
No
Superiority or Other
OG001
OG002
ANCOVA
0.243
This is the p-value for the Right Hippocampal Volume
95
No
Superiority or Other
Units
Counts
Participants
OG00018
OG00123
OG00218
Title
Denominators
Categories
Title
Measurements
OG0000.08± 0.06
OG0010.06± 0.06
OG0020.09± 0.07
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
ANCOVA
0.784
95
No
Superiority or Other
OG000
OG002
ANCOVA
0.931
95
No
Superiority or Other
OG001
OG002
ANCOVA
0.718
95
No
Superiority or Other
Units
Counts
Participants
OG00010
OG00117
OG00218
Title
Denominators
Categories
Title
Measurements
OG00075.11± 92.02
OG00120.50± 69.54
OG00261.00± 59.07
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
ANCOVA
0.634
95
No
Superiority or Other
OG000
OG002
ANCOVA
0.901
95
No
Superiority or Other
OG001
OG002
ANCOVA
0.659
95
No
Superiority or Other
974
Title
Denominators
Categories
Title
Measurements
OG00018.8± 26.8
974
Title
Denominators
Categories
Title
Measurements
OG00066.8± 26.1
Units
Counts
Participants
OG000269
OG001215
OG002199
Title
Denominators
Categories
Title
Measurements
OG0006.52± 0.58
OG0017.98± 0.61
OG0028.33± 0.63
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
0.062
95
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.022
95
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.669
95
No
Superiority or Other
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
OG000270
OG001216
OG002198
Title
Denominators
Categories
Title
Measurements
OG0007.42± 0.63
OG0018.97± 0.67
OG0029.48± 0.69
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
0.071
95
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.018
95
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.571
95
No
Superiority or Other
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
OG000376
OG001289
OG002274
Title
Denominators
Categories
Title
Measurements
OG000-2.95± 0.26
OG001-3.14± 0.27
OG002-3.71± 0.27
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
0.518
95
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.013
95
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.072
95
No
Superiority or Other
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
OG000267
OG001216
OG002195
Title
Denominators
Categories
Title
Measurements
OG0002.31± 0.17
OG0012.73± 0.18
OG0023.04± 0.18
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
0.069
95
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.002
95
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.198
95
No
Superiority or Other
Units
Counts
Participants
OG000369
OG001298
OG002271
Title
Denominators
Categories
Title
Measurements
OG0001.92± 0.75
OG0013.31± 0.79
OG0024.15± 0.81
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
0.127
95
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.016
95
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.381
95
No
Superiority or Other
OG002
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
OG000374
OG001300
OG002275
Title
Denominators
Categories
Title
Measurements
OG000-1.41± 1.11
OG001-7.49± 1.20
OG002-5.33± 1.22
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
<0.001
95
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.005
95
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.141
95
No
Superiority or Other
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
OG00082
OG00198
OG00294
Title
Denominators
Categories
Title
Measurements
OG0000.55± 0.09
OG0010.66± 0.07
OG0020.83± 0.08
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
ANCOVA
0.337
95
No
Superiority or Other
OG000
OG002
ANCOVA
0.018
95
No
Superiority or Other
OG001
OG002
ANCOVA
0.157
95
No
Superiority or Other
Units
Counts
Participants
OG000204
OG001154
OG002146
Title
Denominators
Categories
Title
Measurements
OG0006.97± 0.84
OG0018.27± 0.95
OG0028.41± 0.94
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
0.186
95
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.149
95
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.889
95
No
Superiority or Other
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
OG000204
OG001153
OG002146
Title
Denominators
Categories
Title
Measurements
OG0007.90± 0.93
OG0019.30± 1.06
OG0029.89± 1.04
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
0.202
95
No
Superiority or Other
OG000
OG002
Mixed Models Analysis
0.075
95
No
Superiority or Other
OG001
OG002
Mixed Models Analysis
0.616
95
No
Superiority or Other
OG002
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
OG0000
OG0010
OG0020
OG002
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
OG0000
OG0010
OG0020
OG002
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
OG0000
OG0010
OG0020
OG002
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
OG0000
OG0010
OG0020
OG002
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.