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A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (NAVIGATE-AD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02791191
Recruitment Status : Terminated (Low likelihood of identifying a statistically significant treatment effect.)
First Posted : June 6, 2016
Results First Posted : April 19, 2021
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Drug: LY3202626
Drug: Placebo
Enrollment 316
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 3 mg LY3202626 12 mg LY3202626 Placebo
Hide Arm/Group Description 3 mg LY3202626 administered orally once daily for 52 weeks. 12 mg LY3202626 administered orally once daily for 52 weeks. Placebo administered orally once daily for 52 weeks.
Period Title: Overall Study
Started 55 128 133
Received One Dose of Study Drug 55 127 133
Completed 17 17 13
Not Completed 38 111 120
Reason Not Completed
Adverse Event             2             4             5
Lack of Efficacy             0             1             0
Study Drug Non-Compliance             0             2             0
Site Closed by Sponsor             1             1             3
Progressive Disease             1             0             0
Study Terminated by Sponsor             29             101             109
Withdrawal by Subject             3             1             3
Subject Withdrew Caregiver Circumstances             2             1             0
Arm/Group Title 3 mg LY3202626 12 mg LY3202626 Placebo Total
Hide Arm/Group Description 3 mg LY3202626 administered orally once daily for 52 weeks. 12 mg LY3202626 administered orally once daily for 52 weeks. Placebo administered orally once daily for 52 weeks. Total of all reporting groups
Overall Number of Baseline Participants 55 128 133 316
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 128 participants 133 participants 316 participants
73.91  (6.72) 72.73  (7.15) 72.54  (7.80) 72.86  (7.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 128 participants 133 participants 316 participants
Female 29 86 77 192
Male 26 42 56 124
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 128 participants 133 participants 316 participants
Hispanic or Latino 1 5 7 13
Not Hispanic or Latino 50 108 112 270
Unknown or Not Reported 4 15 14 33
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 128 participants 133 participants 316 participants
American Indian or Alaska Native 0 0 0 0
Asian 8 18 13 39
Native Hawaiian or Other Pacific Islander 1 0 1 2
Black or African American 1 5 4 10
White 45 104 113 262
More than one race 0 1 2 3
Unknown or Not Reported 0 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Canada Number Analyzed 55 participants 128 participants 133 participants 316 participants
0 1 1 2
United States Number Analyzed 55 participants 128 participants 133 participants 316 participants
43 86 105 234
Japan Number Analyzed 55 participants 128 participants 133 participants 316 participants
7 18 12 37
Australia Number Analyzed 55 participants 128 participants 133 participants 316 participants
5 23 15 43
Flortaucipir Standard Uptake Value Ratio (SUVr)   [1] 
Mean (Standard Deviation)
Unit of measure:  Standard uptake value ratio (SUVr)
Number Analyzed 52 participants 121 participants 119 participants 292 participants
1.32  (0.24) 1.36  (0.28) 1.42  (0.35) 1.38  (0.31)
[1]
Measure Analysis Population Description: Participants who completed the baseline ¹⁸F-AV-1451 Positron Emission Tomography (PET) and had evaluable Standard Uptake Value Ratio (SUVr).
1.Primary Outcome
Title Change From Baseline in ¹⁸F-AV-1451 Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at 52 Weeks
Hide Description The 18F-AV-1451 PET tracer assesses change from baseline in the pharmacodynamic effect of 3 mg and 12 mg doses of LY3202626 in participants with mild Alzheimer's disease (AD), compared with placebo at Week 52.The SUVr of ¹⁸F-AV-1451 was modeled using analysis of covariance (ANCOVA) to include the fixed, categorical effects of treatment dose, and the continuous, fixed covariate of baseline Tau PET SUVr and age at baseline.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug, and have baseline and at least one post-baseline scan.
Arm/Group Title 3 mg LY3202626 12 mg LY3202626 Placebo
Hide Arm/Group Description:
3 mg LY3202626 administered orally once daily for 52 weeks.
12 mg LY3202626 administered orally once daily for 52 weeks.
Placebo administered orally once daily for 52 weeks.
Overall Number of Participants Analyzed 15 15 11
Mean (Standard Deviation)
Unit of Measure: Standard Uptake Value Ratio (SUVr)
0.02  (0.04) 0.03  (0.04) 0.01  (0.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3 mg LY3202626, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.418
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 mg LY3202626, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.231
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Emergent Magnetic Resonance Imaging (MRI) Findings
Hide Description Percentage of participants with treatment-emergent MRI findings at Week 52 are summarized here. The mixed-effect model for repeated measures (MMRM) analysis was adjusted for fixed effects of treatment, visit (categorical covariate), treatment-by-visit interaction, baseline age, baseline score (continuous covariate) and baseline-by-visit interaction.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title 3 mg LY3202626 12 mg LY3202626 Placebo
Hide Arm/Group Description:
3 mg LY3202626 administered orally once daily for 52 weeks.
12 mg LY3202626 administered orally once daily for 52 weeks.
Placebo administered orally once daily for 52 weeks.
Overall Number of Participants Analyzed 41 75 62
Measure Type: Number
Unit of Measure: percentage of participants
White Matter Disease 2.4 1.3 1.6
Cortical Infarct 2.4 0.0 0.0
Cortical Superficial Siderous 0.0 1.3 0.0
Lacunar Infarct 0.0 0.0 1.6
Other Infarct 0.0 0.0 1.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3 mg LY3202626, Placebo
Comments White Matter Disease
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 mg LY3202626, Placebo
Comments White Matter Disease
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 3 mg LY3202626, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.404
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 12 mg LY3202626, Placebo
Comments Cortical Superficial Siderous
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 3 mg LY3202626, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Lacunar Infarct
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 12 mg LY3202626, Placebo
Comments Lacunar Infarct
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.457
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 3 mg LY3202626, Placebo
Comments Other Infarct
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 12 mg LY3202626, Placebo
Comments Other Infarct
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.457
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)
Hide Description Percentage of participants with presence of amyloid-related imaging abnormalities-edema (ARIA-E, also known as vasogenic edema) and percentage of an increase in amyloid-related imaging abnormalities-hemorrhage (ARIA-H, also known as also known as microhemorrhage) at Week 52 are summarized here. The mixed-effect model for repeated measures (MMRM) analysis was adjusted for fixed effects of treatment, visit (categorical covariate), treatment-by-visit interaction, baseline age, baseline score (continuous covariate) and baseline-by-visit interaction.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title 3 mg LY3202626 12 mg LY3202626 Placebo
Hide Arm/Group Description:
3 mg LY3202626 administered orally once daily for 52 weeks.
12 mg LY3202626 administered orally once daily for 52 weeks.
Placebo administered orally once daily for 52 weeks.
Overall Number of Participants Analyzed 41 75 62
Measure Type: Number
Unit of Measure: percentage of participants
Presence of Vasogenic Edema 0.0 0.0 1.6
Increase in Microhemorrhages 4.7 6.3 7.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3 mg LY3202626, Placebo
Comments Vasogenic Edema
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 mg LY3202626, Placebo
Comments Vasogenic Edema
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.457
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 3 mg LY3202626, Placebo
Comments Increase in Microhemorrhage
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.703
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 12 mg LY3202626, Placebo
Comments Increase in Microhemorrhage
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores
Hide Description The Columbia-Suicide Severity Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation is defined as a "yes" answer to any 1 of 5 suicidal ideation questions, which includes a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation and behavior are defined as treatment-emergent (TE) if not present during the period up through randomization. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
Time Frame Baseline through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had at least one post-baseline C-SSRS measure.
Arm/Group Title 3 mg LY3202626 12 mg LY3202626 Placebo
Hide Arm/Group Description:
3 mg LY3202626 administered orally once daily for 52 weeks.
12 mg LY3202626 administered orally once daily for 52 weeks.
Placebo administered orally once daily for 52 weeks.
Overall Number of Participants Analyzed 55 127 133
Measure Type: Number
Unit of Measure: percentage of participants
TE Suicidal Ideation Number Analyzed 55 participants 127 participants 133 participants
7.27 7.09 3.76
TE Suicidal Behavior Number Analyzed 55 participants 126 participants 133 participants
1.82 0.79 0.00
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3 mg LY3202626, Placebo
Comments Treatment Emergent Suicidal Ideation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.452
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 mg LY3202626, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.279
Comments TE Suicidal Ideation
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 3 mg LY3202626, Placebo
Comments Emergence of Suicidal Behavior
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.293
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 12 mg LY3202626, Placebo
Comments Emergence of Suicidal Behavior
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.486
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve at Steady State (AUC [T,SS]) of LY3202626
Hide Description PK: AUC [T,SS] of LY3202626
Time Frame Week 2, 4, and 12: Predose and Postdose prior to departing; Week 8 and 16: Postdose after arriving and prior to departing; Week 24: Postdose after cognitive testing
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and have evaluable PK data.
Arm/Group Title 3 mg LY3202626 12 mg LY3202626
Hide Arm/Group Description:
3 mg LY3202626 administered orally once daily for 52 weeks.
12 mg LY3202626 administered orally once daily for 52 weeks.
Overall Number of Participants Analyzed 55 127
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour per milliliter (ng*h/mL)
158
(55.1%)
641
(58.0%)
6.Secondary Outcome
Title Change From Baseline in Plasma Amyloid Beta Aβ₁-₄₀, ₁-₄₂, and 1-x Concentration
Hide Description A mixed model repeated measures (MMRM) analysis will be used to evaluate the change from baseline to Week 52 in plasma Aβ₁-₄₀, Aβ₁-₄₂, and Aβ 1-x. The model for the fixed effects will include terms for the following independent effects: log transformed baseline plasma Aβ, treatment, visit, treatment-by-visit interaction.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug, and have baseline and at least one post-baseline measure.
Arm/Group Title 3 mg LY3202626 12 mg LY3202626 Placebo
Hide Arm/Group Description:
3 mg LY3202626 administered orally once daily for 52 weeks.
12 mg LY3202626 administered orally once daily for 52 weeks.
Placebo administered orally once daily for 52 weeks.
Overall Number of Participants Analyzed 55 127 133
Mean (Standard Deviation)
Unit of Measure: nanograms per liter (ng/L)
Amyloid Beta Number Analyzed 13 participants 17 participants 14 participants
-258.7  (64) -286.1  (85.9) -12.0  (80.5)
Amyloid Beta 1-40 Number Analyzed 14 participants 17 participants 15 participants
-157.3  (65.6) -149.3  (38.0) -17.0  (38.2)
Amyloid Beta 1-42 Number Analyzed 14 participants 17 participants 15 participants
-46.3  (38.7) -50.0  (34.1) 0.0  (5.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3 mg LY3202626, Placebo
Comments Amyloid Beta
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 mg LY3202626, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Amyloid Beta
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 3 mg LY3202626, Placebo
Comments Amyloid Beta 1-40
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 12 mg LY3202626, Placebo
Comments Amyloid Beta 1-40
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 3 mg LY3202626, Placebo
Comments Amyloid Beta 1-42
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 12 mg LY3202626, Placebo
Comments Amyloid Beta 1-42
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog₁₃)
Hide Description The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS that was used as the primary efficacy measure consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS--Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. A mixed model repeated measures (MMRM) was used in analysis. The model included fixed, categorical effects of treatment, visit and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug, and have baseline and at least one post-baseline ADAS-Cog₁₃ measure.
Arm/Group Title 3 mg LY3202626 12 mg LY3202626 Placebo
Hide Arm/Group Description:
3 mg LY3202626 administered orally once daily for 52 weeks.
12 mg LY3202626 administered orally once daily for 52 weeks.
Placebo administered orally once daily for 52 weeks.
Overall Number of Participants Analyzed 17 19 15
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
3.05  (1.40) 1.88  (1.33) 2.97  (1.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3 mg LY3202626, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.970
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 mg LY3202626, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.586
Comments [Not Specified]
Method Mixed Model Repeated Meausres
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory (ADCS-iADL)
Hide Description The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities (instrumental activity items 7-23) of daily living by participants. The range for the ADCS-iADL is 0-56 with higher scores reflecting better performance. ADCS-iADL was analyzed using mixed-model repeated measures (MMRM), Least Square (LS) Mean was controlled for treatment, visit, treatment-by-visit interaction, baseline age, baseline score and baseline-by-visit interaction.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug, and have baseline and at least one post-baseline ADCS-iADL measure.
Arm/Group Title 3 mg LY3202626 12 mg LY3202626 Placebo
Hide Arm/Group Description:
3 mg LY3202626 administered orally once daily for 52 weeks.
12 mg LY3202626 administered orally once daily for 52 weeks.
Placebo administered orally once daily for 52 weeks.
Overall Number of Participants Analyzed 17 19 15
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.97  (1.34) -4.63  (1.24) -7.32  (1.38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3 mg LY3202626, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 mg LY3202626, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.150
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
Hide Description The iADRS comprises scores form the ADAS-Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 9score range 0 to 85 with higher scores reflecting worse performance and the ADCS-iADL (score range 0-56 with higher scores reflecting better performance). The iADRS score ranges from 0 to 141 with lower scores indicating worse performance. iADRS was analyzed using mixed-model repeated measures (MMRM); Least Square (LS) Mean was controlled for treatment, visit, treatment-by-visit interaction, baseline age, baseline score and baseline-by-visit interaction.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug, and have baseline and at least one post-baseline iADRS measure.
Arm/Group Title 3 mg LY3202626 12 mg LY3202626 Placebo
Hide Arm/Group Description:
3 mg LY3202626 administered orally once daily for 52 weeks.
12 mg LY3202626 administered orally once daily for 52 weeks.
Placebo administered orally once daily for 52 weeks.
Overall Number of Participants Analyzed 16 19 15
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.01  (2.07) -6.45  (1.90) -10.32  (2.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3 mg LY3202626, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.153
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 mg LY3202626, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.176
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame Up to 56 Weeks
Adverse Event Reporting Description All randomized participants.
 
Arm/Group Title 3 mg LY3202626 12 mg LY3202626 Placebo
Hide Arm/Group Description 3 mg LY3202626 administered orally once daily for 52 weeks. 12 mg LY3202626 administered orally once daily for 52 weeks Placebo administered orally once daily for 52 weeks.
All-Cause Mortality
3 mg LY3202626 12 mg LY3202626 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)      0/127 (0.00%)      0/133 (0.00%)    
Hide Serious Adverse Events
3 mg LY3202626 12 mg LY3202626 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/55 (18.18%)      8/127 (6.30%)      10/133 (7.52%)    
Blood and lymphatic system disorders       
Haemorrhagic anaemia † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Cardiac disorders       
Angina pectoris † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 1/133 (0.75%)  1
Cardiac failure congestive † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Coronary artery disease † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Gastrointestinal disorders       
Duodenal ulcer † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Gastrointestinal haemorrhage † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Small intestinal obstruction † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
General disorders       
Chest discomfort † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Gait disturbance † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 0/133 (0.00%)  0
Pyrexia † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Infections and infestations       
Cystitis † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Influenza † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Pneumonia † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Pyuria † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Injury, poisoning and procedural complications       
Accidental overdose † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Ankle fracture † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Confusion postoperative † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Fall † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 1/133 (0.75%)  1
Hip fracture † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Spinal compression fracture † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Metabolism and nutrition disorders       
Dehydration † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Diabetes mellitus inadequate control † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Hypocalcaemia † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Lactic acidosis † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Musculoskeletal and connective tissue disorders       
Spinal column stenosis † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Nervous system disorders       
Metabolic encephalopathy † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Syncope † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Transient global amnesia † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Product Issues       
Device breakage † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Psychiatric disorders       
Aggression † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Suicidal ideation † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Suicide attempt † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Renal and urinary disorders       
Urinary retention † 1  1/55 (1.82%)  3 0/127 (0.00%)  0 0/133 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
3 mg LY3202626 12 mg LY3202626 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/55 (83.64%)      97/127 (76.38%)      91/133 (68.42%)    
Blood and lymphatic system disorders       
Anaemia † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Thrombocytopenia † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Cardiac disorders       
Angina pectoris † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Arrhythmia † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Atrial fibrillation † 1  3/55 (5.45%)  3 2/127 (1.57%)  2 1/133 (0.75%)  1
Atrioventricular block first degree † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Bradycardia † 1  1/55 (1.82%)  1 2/127 (1.57%)  2 0/133 (0.00%)  0
Cardiac failure congestive † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 0/133 (0.00%)  0
Coronary artery disease † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 1/133 (0.75%)  1
Left ventricular failure † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Tachyarrhythmia † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Ear and labyrinth disorders       
Cerumen impaction † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Otorrhoea † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Tinnitus † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 3/133 (2.26%)  3
Vertigo † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Endocrine disorders       
Goitre † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Hyperparathyroidism secondary † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Hypothyroidism † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Eye disorders       
Cataract † 1  3/55 (5.45%)  3 1/127 (0.79%)  1 1/133 (0.75%)  2
Cataract nuclear † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Conjunctival haemorrhage † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Corneal oedema † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Diplopia † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 1/133 (0.75%)  1
Dyschromatopsia † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 1/133 (0.75%)  1
Erythropsia † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Eye pain † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 0/133 (0.00%)  0
Eye swelling † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Eyelid cyst † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Eyelid oedema † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Glaucoma † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 0/133 (0.00%)  0
Lacrimation increased † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Lenticular opacities † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Macular degeneration † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Macular fibrosis † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 1/133 (0.75%)  1
Macular oedema † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Normal tension glaucoma † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Ocular hyperaemia † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Optic disc disorder † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Optic disc haemorrhage † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Photopsia † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Posterior capsule opacification † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Retinal drusen † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Retinal haemorrhage † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Visual acuity reduced † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 2/133 (1.50%)  2
Visual impairment † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 0/133 (0.00%)  0
Vitreous detachment † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 1/133 (0.75%)  1
Gastrointestinal disorders       
Abdominal discomfort † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Abdominal distension † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Abdominal hernia † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Abdominal pain † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 0/133 (0.00%)  0
Abdominal pain upper † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 0/133 (0.00%)  0
Abdominal tenderness † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Aphthous ulcer † 1  2/55 (3.64%)  2 0/127 (0.00%)  0 0/133 (0.00%)  0
Barrett's oesophagus † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Constipation † 1  2/55 (3.64%)  2 5/127 (3.94%)  5 1/133 (0.75%)  2
Dental caries † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Diarrhoea † 1  2/55 (3.64%)  2 6/127 (4.72%)  7 6/133 (4.51%)  7
Dry mouth † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 0/133 (0.00%)  0
Dyspepsia † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 1/133 (0.75%)  1
Dysphagia † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Faeces discoloured † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Flatulence † 1  2/55 (3.64%)  2 0/127 (0.00%)  0 0/133 (0.00%)  0
Functional gastrointestinal disorder † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Gastric ulcer haemorrhage † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Gastrooesophageal reflux disease † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 2/133 (1.50%)  2
Haemorrhoids † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Hiatus hernia † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Hyperchlorhydria † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Large intestinal obstruction † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Nausea † 1  1/55 (1.82%)  1 2/127 (1.57%)  2 4/133 (3.01%)  4
Oral disorder † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Toothache † 1  0/55 (0.00%)  0 3/127 (2.36%)  3 0/133 (0.00%)  0
Vomiting † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 2/133 (1.50%)  2
General disorders       
Asthenia † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 0/133 (0.00%)  0
Chest discomfort † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Chest pain † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 2/133 (1.50%)  2
Chills † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Crying † 1  2/55 (3.64%)  2 1/127 (0.79%)  1 0/133 (0.00%)  0
Fatigue † 1  0/55 (0.00%)  0 5/127 (3.94%)  5 7/133 (5.26%)  7
Feeling abnormal † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Feeling cold † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Feeling jittery † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Gait disturbance † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 2/133 (1.50%)  2
Influenza like illness † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Injection site rash † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Malaise † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Non-cardiac chest pain † 1  0/55 (0.00%)  0 6/127 (4.72%)  7 1/133 (0.75%)  1
Oedema † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Oedema peripheral † 1  1/55 (1.82%)  1 4/127 (3.15%)  5 2/133 (1.50%)  2
Pain † 1  0/55 (0.00%)  0 2/127 (1.57%)  3 0/133 (0.00%)  0
Peripheral swelling † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 0/133 (0.00%)  0
Pyrexia † 1  0/55 (0.00%)  0 3/127 (2.36%)  3 0/133 (0.00%)  0
Unevaluable event † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Vessel puncture site haematoma † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Hepatobiliary disorders       
Cholecystitis chronic † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Cholelithiasis † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 1/133 (0.75%)  1
Immune system disorders       
Allergy to animal † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Hypersensitivity † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Mite allergy † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Mycotic allergy † 1  1/55 (1.82%)  2 0/127 (0.00%)  0 0/133 (0.00%)  0
Seasonal allergy † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 0/133 (0.00%)  0
Infections and infestations       
Acute sinusitis † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Bronchitis † 1  2/55 (3.64%)  2 1/127 (0.79%)  1 3/133 (2.26%)  3
Cellulitis † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Clostridium difficile infection † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Conjunctivitis † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Dermatitis infected † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Diverticulitis † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
External ear cellulitis † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Folliculitis † 1  2/55 (3.64%)  2 1/127 (0.79%)  1 0/133 (0.00%)  0
Fungal skin infection † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Gastroenteritis † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Hepatitis e † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Herpes zoster † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 1/133 (0.75%)  1
Hordeolum † 1  2/55 (3.64%)  2 0/127 (0.00%)  0 2/133 (1.50%)  2
Influenza † 1  2/55 (3.64%)  2 4/127 (3.15%)  4 3/133 (2.26%)  3
Laryngitis † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Localised infection † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Lower respiratory tract infection † 1  0/55 (0.00%)  0 1/127 (0.79%)  3 0/133 (0.00%)  0
Nail bed infection bacterial † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Nasopharyngitis † 1  7/55 (12.73%)  7 14/127 (11.02%)  16 7/133 (5.26%)  7
Onychomycosis † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Oral herpes † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Otitis externa † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Otitis media † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Pharyngitis † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 0/133 (0.00%)  0
Rhinitis † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Sinusitis † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 1/133 (0.75%)  1
Tinea versicolour † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Tooth infection † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Upper respiratory tract infection † 1  5/55 (9.09%)  5 6/127 (4.72%)  6 7/133 (5.26%)  8
Urinary tract infection † 1  3/55 (5.45%)  5 7/127 (5.51%)  8 3/133 (2.26%)  3
Viral infection † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Viral upper respiratory tract infection † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Vulvovaginal candidiasis † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Injury, poisoning and procedural complications       
Arthropod bite † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 1/133 (0.75%)  1
Back injury † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Compression fracture † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Contusion † 1  1/55 (1.82%)  1 11/127 (8.66%)  12 4/133 (3.01%)  4
Eye contusion † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Fall † 1  1/55 (1.82%)  2 8/127 (6.30%)  12 8/133 (6.02%)  9
Fracture displacement † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Incision site pain † 1  1/55 (1.82%)  2 0/127 (0.00%)  0 0/133 (0.00%)  0
Joint dislocation † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Joint injury † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Laceration † 1  0/55 (0.00%)  0 4/127 (3.15%)  4 2/133 (1.50%)  2
Ligament sprain † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Limb injury † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 0/133 (0.00%)  0
Lower limb fracture † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Meniscus injury † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Muscle rupture † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Overdose † 1  1/55 (1.82%)  2 0/127 (0.00%)  0 0/133 (0.00%)  0
Post procedural haematuria † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Post procedural swelling † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Rib fracture † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 3/133 (2.26%)  3
Skin abrasion † 1  3/55 (5.45%)  3 1/127 (0.79%)  1 2/133 (1.50%)  2
Spinal compression fracture † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Synovial rupture † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Upper limb fracture † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Wrist fracture † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 0/133 (0.00%)  0
Investigations       
Alanine aminotransferase increased † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Aspartate aminotransferase increased † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 0/133 (0.00%)  0
Biopsy skin † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 1/133 (0.75%)  1
Blood alkaline phosphatase increased † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Blood cholesterol increased † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Blood creatine phosphokinase increased † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 1/133 (0.75%)  1
Blood creatinine increased † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 2/133 (1.50%)  2
Blood pressure increased † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Cardiac murmur † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Colonoscopy † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Cystoscopy † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Electrocardiogram qt prolonged † 1  1/55 (1.82%)  1 3/127 (2.36%)  3 1/133 (0.75%)  1
Fibrin d dimer increased † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Haemoglobin decreased † 1  2/55 (3.64%)  2 1/127 (0.79%)  1 0/133 (0.00%)  0
Hepatic enzyme increased † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 2/133 (1.50%)  2
Low density lipoprotein increased † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Mammogram abnormal † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Oxygen saturation decreased † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Staphylococcus test positive † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Transaminases increased † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Tri-iodothyronine decreased † 1  1/55 (1.82%)  1 2/127 (1.57%)  2 1/133 (0.75%)  1
Weight decreased † 1  2/55 (3.64%)  2 1/127 (0.79%)  1 3/133 (2.26%)  3
Metabolism and nutrition disorders       
Decreased appetite † 1  0/55 (0.00%)  0 3/127 (2.36%)  3 1/133 (0.75%)  1
Dehydration † 1  2/55 (3.64%)  2 2/127 (1.57%)  2 1/133 (0.75%)  1
Diabetes mellitus † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Dyslipidaemia † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Gout † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Hypercalcaemia † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Hypercholesterolaemia † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Hyperglycaemia † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Hyperlipidaemia † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Hypoglycaemia † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Hypokalaemia † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Vitamin d deficiency † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  2/55 (3.64%)  2 4/127 (3.15%)  4 8/133 (6.02%)  8
Arthritis † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 0/133 (0.00%)  0
Back pain † 1  1/55 (1.82%)  1 2/127 (1.57%)  2 1/133 (0.75%)  1
Bursitis † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Exostosis † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Foot deformity † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Intervertebral disc degeneration † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Intervertebral disc protrusion † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Joint space narrowing † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Joint swelling † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Mobility decreased † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Muscle spasms † 1  4/55 (7.27%)  4 0/127 (0.00%)  0 1/133 (0.75%)  1
Musculoskeletal pain † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 0/133 (0.00%)  0
Myalgia † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Neck pain † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Osteoarthritis † 1  1/55 (1.82%)  1 2/127 (1.57%)  2 1/133 (0.75%)  1
Osteopenia † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Osteoporosis † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 1/133 (0.75%)  1
Pain in extremity † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 3/133 (2.26%)  3
Periarthritis † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Rheumatoid arthritis † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Rotator cuff syndrome † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 1/133 (0.75%)  1
Scoliosis † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Spinal osteoarthritis † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Synovial cyst † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Tendonitis † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 0/133 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Acrochordon † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Basal cell carcinoma † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Bowen's disease † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Breast cancer † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Dysplastic naevus † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Seborrhoeic keratosis † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 0/133 (0.00%)  0
Skin papilloma † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Squamous cell carcinoma † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 4/133 (3.01%)  4
Nervous system disorders       
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 2/133 (1.50%)  2
Amyloid related imaging abnormality-oedema/effusion † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Aphasia † 1  0/55 (0.00%)  0 3/127 (2.36%)  3 0/133 (0.00%)  0
Ataxia † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Balance disorder † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Carpal tunnel syndrome † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Cerebellar infarction † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Cerebellar microhaemorrhage † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Cerebellar syndrome † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Cerebral microhaemorrhage † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 2/133 (1.50%)  2
Corticobasal degeneration † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Dementia alzheimer's type † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 1/133 (0.75%)  1
Dizziness † 1  2/55 (3.64%)  2 3/127 (2.36%)  3 4/133 (3.01%)  4
Dizziness postural † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Dysgeusia † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Essential tremor † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Extrapyramidal disorder † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Head discomfort † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Headache † 1  5/55 (9.09%)  5 4/127 (3.15%)  4 2/133 (1.50%)  2
Hypersomnia † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Hypogeusia † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Lethargy † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 0/133 (0.00%)  0
Loss of consciousness † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Memory impairment † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 0/133 (0.00%)  0
Migraine † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Nervous system disorder † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Paraesthesia † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Poor quality sleep † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Presyncope † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 2/133 (1.50%)  2
Somnolence † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Superficial siderosis of central nervous system † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Syncope † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 2/133 (1.50%)  2
Thalamic infarction † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Tremor † 1  0/55 (0.00%)  0 3/127 (2.36%)  3 0/133 (0.00%)  0
Vertebral artery stenosis † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Psychiatric disorders       
Abnormal dreams † 1  0/55 (0.00%)  0 3/127 (2.36%)  4 2/133 (1.50%)  2
Affect lability † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Agitation † 1  1/55 (1.82%)  2 1/127 (0.79%)  1 3/133 (2.26%)  3
Anxiety † 1  3/55 (5.45%)  3 4/127 (3.15%)  4 0/133 (0.00%)  0
Confusional state † 1  3/55 (5.45%)  4 3/127 (2.36%)  3 1/133 (0.75%)  1
Delusion † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Depressed mood † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Depression † 1  2/55 (3.64%)  2 3/127 (2.36%)  3 3/133 (2.26%)  4
Disorientation † 1  1/55 (1.82%)  1 1/127 (0.79%)  2 0/133 (0.00%)  0
Emotional distress † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Generalised anxiety disorder † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Hallucination † 1  1/55 (1.82%)  1 6/127 (4.72%)  6 2/133 (1.50%)  2
Hallucination, auditory † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Hallucination, visual † 1  0/55 (0.00%)  0 4/127 (3.15%)  4 0/133 (0.00%)  0
Hypnopompic hallucination † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 0/133 (0.00%)  0
Insomnia † 1  3/55 (5.45%)  3 0/127 (0.00%)  0 1/133 (0.75%)  1
Mania † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Mental status changes † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Mood altered † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Mood swings † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Nightmare † 1  1/55 (1.82%)  1 4/127 (3.15%)  5 0/133 (0.00%)  0
Psychotic disorder † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Sleep disorder † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Suicidal ideation † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Tension † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Dysuria † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Haematuria † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 0/133 (0.00%)  0
Hypertonic bladder † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 0/133 (0.00%)  0
Lower urinary tract symptoms † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Nephrolithiasis † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Pollakiuria † 1  0/55 (0.00%)  0 3/127 (2.36%)  3 1/133 (0.75%)  1
Renal cyst † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 1/133 (0.75%)  1
Renal mass † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Reproductive system and breast disorders       
Benign prostatic hyperplasia † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Breast cyst † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Breast mass † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Breast pain † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Genital rash † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Respiratory, thoracic and mediastinal disorders       
Asthma † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 0/133 (0.00%)  0
Atelectasis † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Cough † 1  6/55 (10.91%)  6 5/127 (3.94%)  5 2/133 (1.50%)  3
Dyspnoea † 1  2/55 (3.64%)  2 2/127 (1.57%)  2 0/133 (0.00%)  0
Dyspnoea exertional † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  2
Lower respiratory tract congestion † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Nasal congestion † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 1/133 (0.75%)  1
Oropharyngeal pain † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Pleuritic pain † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Pneumothorax † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Rhinitis allergic † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Rhinorrhoea † 1  0/55 (0.00%)  0 3/127 (2.36%)  3 0/133 (0.00%)  0
Skin and subcutaneous tissue disorders       
Actinic keratosis † 1  0/55 (0.00%)  0 3/127 (2.36%)  3 3/133 (2.26%)  4
Dermatitis † 1  0/55 (0.00%)  0 1/127 (0.79%)  2 1/133 (0.75%)  1
Dermatitis atopic † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Dermatitis contact † 1  5/55 (9.09%)  5 1/127 (0.79%)  1 1/133 (0.75%)  1
Dry skin † 1  1/55 (1.82%)  1 2/127 (1.57%)  2 0/133 (0.00%)  0
Eczema † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Eczema asteatotic † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Erythema † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Hair colour changes † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Hyperhidrosis † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 2/133 (1.50%)  2
Idiopathic guttate hypomelanosis † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Ingrowing nail † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Leukoderma † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Nail disorder † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Night sweats † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 1/133 (0.75%)  1
Pruritus † 1  0/55 (0.00%)  0 1/127 (0.79%)  2 1/133 (0.75%)  3
Psoriasis † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Rash † 1  1/55 (1.82%)  1 1/127 (0.79%)  1 2/133 (1.50%)  2
Rash macular † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Rash papular † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Seborrhoeic dermatitis † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Skin hypopigmentation † 1  2/55 (3.64%)  2 0/127 (0.00%)  0 1/133 (0.75%)  1
Skin irritation † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Skin lesion † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  1
Solar lentigo † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 1/133 (0.75%)  3
Splinter haemorrhages † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Telangiectasia † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Social circumstances       
Orthosis user † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Walking aid user † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Surgical and medical procedures       
Blepharectomy † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Bursa removal † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Cataract operation † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 2/133 (1.50%)  3
Catheter placement † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Chest tube insertion † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Cochlea implant † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Coronary artery bypass † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Dental implantation † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Endodontic procedure † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Internal fixation of fracture † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Intraocular lens implant † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Knee arthroplasty † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Lens capsulotomy † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Medical device removal † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Micrographic skin surgery † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Nasal operation † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Open reduction of fracture † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Papilloma excision † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Skin neoplasm excision † 1  1/55 (1.82%)  1 2/127 (1.57%)  2 0/133 (0.00%)  0
Spinal fusion surgery † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Tooth extraction † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 1/133 (0.75%)  1
Transurethral prostatectomy † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 1/133 (0.75%)  1
Vertebroplasty † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Vascular disorders       
Aortic disorder † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Arteriosclerosis † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Flushing † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 0/133 (0.00%)  0
Haematoma † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 2/133 (1.50%)  2
Hot flush † 1  0/55 (0.00%)  0 0/127 (0.00%)  0 1/133 (0.75%)  1
Hypertension † 1  1/55 (1.82%)  1 0/127 (0.00%)  0 1/133 (0.75%)  1
Hypotension † 1  0/55 (0.00%)  0 2/127 (1.57%)  2 0/133 (0.00%)  0
Orthostatic hypertension † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
Orthostatic hypotension † 1  1/55 (1.82%)  1 5/127 (3.94%)  5 1/133 (0.75%)  1
Supine hypertension † 1  0/55 (0.00%)  0 1/127 (0.79%)  1 0/133 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
Study was terminated due to low likelihood of identifying a statistically significant treatment effect.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5079
EMail: Clinicaltrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02791191    
Other Study ID Numbers: 16223
I7X-MC-LLCF ( Other Identifier: Eli Lilly and Company )
First Submitted: June 1, 2016
First Posted: June 6, 2016
Results First Submitted: March 22, 2021
Results First Posted: April 19, 2021
Last Update Posted: April 19, 2021