Trial Outcomes & Findings for A Study of LY2541546 in Healthy Postmenopausal Women (NCT NCT01742078)
NCT ID: NCT01742078
Last Updated: 2019-01-23
Results Overview
An SAE is any AE from this study that results in one of the following outcomes: * death * initial or prolonged inpatient hospitalization * a life-threatening experience (that is, immediate risk of dying) * persistent or significant disability/incapacity * congenital anomaly/birth defect * or is considered significant by the investigator for any other reason.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Day 1 through Day 85
Results posted on
2019-01-23
Participant Flow
Participant milestones
| Measure |
7.5 mg LY2541546 - IV
Single dose of 7.5 mg LY2541546 administered intravenously (IV)
|
25 mg LY2541546 - IV
Single dose of 25 mg LY2541546 administered IV
|
75 mg LY2541546 - IV
Single dose of 75 mg LY2541546 administered IV
|
225 mg LY2541546 - IV
Single dose of 225 mg LY2541546 administered IV
|
750 mg LY2541546 - IV
Single dose of 750 mg LY2541546 administered IV
|
150 mg LY2541546 - SC
Single dose of 150 mg LY2541546 administered subcutaneous (SC)
|
225 mg LY2541546 - IV, OL
Single dose of 225 mg LY2541546 administered IV, open label (OL)
|
750 mg LY2541546 - IV, OL
Single dose of 750 mg LY2541546 administered IV, OL
|
Placebo
Single dose of placebo administered IV or SC
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
12
|
|
Overall Study
RECEIVED STUDY DRUG
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
12
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
5
|
6
|
6
|
6
|
6
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
7.5 mg LY2541546 - IV
Single dose of 7.5 mg LY2541546 administered intravenously (IV)
|
25 mg LY2541546 - IV
Single dose of 25 mg LY2541546 administered IV
|
75 mg LY2541546 - IV
Single dose of 75 mg LY2541546 administered IV
|
225 mg LY2541546 - IV
Single dose of 225 mg LY2541546 administered IV
|
750 mg LY2541546 - IV
Single dose of 750 mg LY2541546 administered IV
|
150 mg LY2541546 - SC
Single dose of 150 mg LY2541546 administered subcutaneous (SC)
|
225 mg LY2541546 - IV, OL
Single dose of 225 mg LY2541546 administered IV, open label (OL)
|
750 mg LY2541546 - IV, OL
Single dose of 750 mg LY2541546 administered IV, OL
|
Placebo
Single dose of placebo administered IV or SC
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY2541546 in Healthy Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Total
n=60 Participants
Total of all reporting groups
|
7.5 mg LY2541546 - IV
n=6 Participants
Participants received 7.5 mg LY2541546 IV
|
25 mg LY2541546 - IV
n=6 Participants
Participants received25 mg LY2541546 IV
|
75 mg LY2541546 - IV
n=6 Participants
Participants received 75 mg LY2541546 IV
|
225 mg LY2541546 - IV
n=6 Participants
Participants received225 mg LY541546 IV
|
750 mg LY2541546 - IV
n=6 Participants
Participants received750 mg LY2541546 IV
|
150 mg LY2541546 - SC
n=6 Participants
Participants received 150 mg LY2541546 subcutaneously (SC)
|
225 mg LY2541546 - IV, OL
n=6 Participants
Participants received 225 mg LY2541546 IV. Open label(OL)
|
750 mg LY2541546 - IV, OL
n=6 Participants
Participants received 750 mg LY2541546 IV, OL
|
Placebo
n=12 Participants
Participants single dose of placebo administered IV or SC
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 5.8 • n=64 Participants
|
54.0 years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 4.6 • n=4 Participants
|
59.0 years
STANDARD_DEVIATION 5.7 • n=21 Participants
|
58.5 years
STANDARD_DEVIATION 4.5 • n=10 Participants
|
59.7 years
STANDARD_DEVIATION 6.7 • n=115 Participants
|
64.2 years
STANDARD_DEVIATION 5.9 • n=6 Participants
|
57.1 years
STANDARD_DEVIATION 5.2 • n=6 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=64 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
12 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=64 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
55 Participants
n=64 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
11 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
African
|
3 Participants
n=64 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=64 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
West Asian
|
1 Participants
n=64 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=64 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
12 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 85Population: All participants who received study drug.
An SAE is any AE from this study that results in one of the following outcomes: * death * initial or prolonged inpatient hospitalization * a life-threatening experience (that is, immediate risk of dying) * persistent or significant disability/incapacity * congenital anomaly/birth defect * or is considered significant by the investigator for any other reason.
Outcome measures
| Measure |
7.5 mg LY2541546 - IV
n=6 Participants
Single dose of 7.5 mg LY2541546 administered intravenously (IV)
|
25 mg LY2541546 - IV
n=6 Participants
Single dose of 25 mg LY2541546 administered IV
|
75 mg LY2541546 - IV
n=6 Participants
Single dose of 75 mg LY2541546 administered IV
|
225 mg LY2541546 - IV
n=6 Participants
Single dose of 225 mg LY2541546 administered IV
|
750 mg LY2541546 - IV
n=6 Participants
Single dose of 750 mg LY2541546 administered IV
|
150 mg LY2541546 - SC
n=6 Participants
Single dose of 150 mg LY2541546 administered subcutaneous (SC)
|
Placebo
n=12 Participants
Single dose of placebo administered IV or SC
|
225 mg LY2541546 - IV, OL
n=6 Participants
Single dose of 225 mg LY2541546 administered IV, open label (OL)
|
750 mg LY2541546 - IV, OL
n=6 Participants
Single dose of 750 mg LY2541546 administered IV, OL
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1: Predose,30 minutes,45 mintues,1 hour (hr), 1.5 hr, 3 hr, 6 hr, 12 hr Postdose; Day (D) 3,D5 ,D8, D11, D15, D29, D43, D57, D71,D85: anytimePopulation: All participants who received study drug and had sufficient evaluable results for PK analysis.
Outcome measures
| Measure |
7.5 mg LY2541546 - IV
n=6 Participants
Single dose of 7.5 mg LY2541546 administered intravenously (IV)
|
25 mg LY2541546 - IV
n=6 Participants
Single dose of 25 mg LY2541546 administered IV
|
75 mg LY2541546 - IV
n=5 Participants
Single dose of 75 mg LY2541546 administered IV
|
225 mg LY2541546 - IV
n=6 Participants
Single dose of 225 mg LY2541546 administered IV
|
750 mg LY2541546 - IV
n=6 Participants
Single dose of 750 mg LY2541546 administered IV
|
150 mg LY2541546 - SC
n=6 Participants
Single dose of 150 mg LY2541546 administered subcutaneous (SC)
|
Placebo
n=6 Participants
Single dose of placebo administered IV or SC
|
225 mg LY2541546 - IV, OL
n=6 Participants
Single dose of 225 mg LY2541546 administered IV, open label (OL)
|
750 mg LY2541546 - IV, OL
Single dose of 750 mg LY2541546 administered IV, OL
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546
|
411 picomol*hr/mL
Geometric Coefficient of Variation 51
|
2540 picomol*hr/mL
Geometric Coefficient of Variation 22
|
16400 picomol*hr/mL
Geometric Coefficient of Variation 16
|
86600 picomol*hr/mL
Geometric Coefficient of Variation 14
|
390000 picomol*hr/mL
Geometric Coefficient of Variation 14
|
9150 picomol*hr/mL
Geometric Coefficient of Variation 40
|
94500 picomol*hr/mL
Geometric Coefficient of Variation 10
|
507000 picomol*hr/mL
Geometric Coefficient of Variation 14
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose), Day 29 anytime, Day 85 anytimePopulation: All participants who received study drug and had evaluable results at the analyzed time points.
A BMD test measures the amount of mineral (such as calcium) in a defined area of bone in grams per square centimeter (g/cm²) and is calculate by dexascan.
Outcome measures
| Measure |
7.5 mg LY2541546 - IV
n=6 Participants
Single dose of 7.5 mg LY2541546 administered intravenously (IV)
|
25 mg LY2541546 - IV
n=6 Participants
Single dose of 25 mg LY2541546 administered IV
|
75 mg LY2541546 - IV
n=6 Participants
Single dose of 75 mg LY2541546 administered IV
|
225 mg LY2541546 - IV
n=6 Participants
Single dose of 225 mg LY2541546 administered IV
|
750 mg LY2541546 - IV
n=6 Participants
Single dose of 750 mg LY2541546 administered IV
|
150 mg LY2541546 - SC
n=6 Participants
Single dose of 150 mg LY2541546 administered subcutaneous (SC)
|
Placebo
n=12 Participants
Single dose of placebo administered IV or SC
|
225 mg LY2541546 - IV, OL
n=6 Participants
Single dose of 225 mg LY2541546 administered IV, open label (OL)
|
750 mg LY2541546 - IV, OL
n=6 Participants
Single dose of 750 mg LY2541546 administered IV, OL
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD)
Day 85
|
-0.00 gram per square centimeter (g/cm^2)
Interval -0.02 to 0.01
|
-0.01 gram per square centimeter (g/cm^2)
Interval -0.02 to 0.01
|
0.01 gram per square centimeter (g/cm^2)
Interval 0.0 to 0.03
|
0.02 gram per square centimeter (g/cm^2)
Interval 0.0 to 0.03
|
0.03 gram per square centimeter (g/cm^2)
Interval 0.02 to 0.05
|
0.01 gram per square centimeter (g/cm^2)
Interval 0.0 to 0.02
|
-0.00 gram per square centimeter (g/cm^2)
Interval -0.02 to 0.01
|
0.01 gram per square centimeter (g/cm^2)
Interval -0.01 to 0.02
|
0.02 gram per square centimeter (g/cm^2)
Interval 0.0 to 0.03
|
|
Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD)
Day 29
|
0.01 gram per square centimeter (g/cm^2)
Interval -0.01 to 0.02
|
-0.01 gram per square centimeter (g/cm^2)
Interval -0.03 to 0.01
|
0.01 gram per square centimeter (g/cm^2)
Interval 0.0 to 0.02
|
0.01 gram per square centimeter (g/cm^2)
Interval 0.0 to 0.03
|
0.00 gram per square centimeter (g/cm^2)
Interval -0.01 to 0.02
|
0.00 gram per square centimeter (g/cm^2)
Interval -0.01 to 0.01
|
-0.00 gram per square centimeter (g/cm^2)
Interval -0.01 to 0.01
|
0.01 gram per square centimeter (g/cm^2)
Interval 0.0 to 0.03
|
-0.00 gram per square centimeter (g/cm^2)
Interval -0.02 to 0.01
|
SECONDARY outcome
Timeframe: Baseline (predose), Day 29 anytime, Day 85 anytimePopulation: All participants who received study drug and had evaluable results at the analyzed timepoints.
N-terminal propeptide of procollagen type 1 (P1NP) is a main bone formation marker. An increase of P1NP in serum reflects elevated anabolic activities of the bone. Percentage change in P1NP from baseline to post baseline time points was analyzed using the repeated-measures model.
Outcome measures
| Measure |
7.5 mg LY2541546 - IV
n=6 Participants
Single dose of 7.5 mg LY2541546 administered intravenously (IV)
|
25 mg LY2541546 - IV
n=6 Participants
Single dose of 25 mg LY2541546 administered IV
|
75 mg LY2541546 - IV
n=6 Participants
Single dose of 75 mg LY2541546 administered IV
|
225 mg LY2541546 - IV
n=6 Participants
Single dose of 225 mg LY2541546 administered IV
|
750 mg LY2541546 - IV
n=6 Participants
Single dose of 750 mg LY2541546 administered IV
|
150 mg LY2541546 - SC
n=6 Participants
Single dose of 150 mg LY2541546 administered subcutaneous (SC)
|
Placebo
n=12 Participants
Single dose of placebo administered IV or SC
|
225 mg LY2541546 - IV, OL
n=6 Participants
Single dose of 225 mg LY2541546 administered IV, open label (OL)
|
750 mg LY2541546 - IV, OL
n=6 Participants
Single dose of 750 mg LY2541546 administered IV, OL
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)
Day 29
|
9.36 percentage of change from baseline
Interval -38.79 to 57.52
|
44.00 percentage of change from baseline
Interval -4.15 to 92.16
|
24.86 percentage of change from baseline
Interval -23.3 to 73.01
|
47.54 percentage of change from baseline
Interval -2.5 to 97.59
|
224.16 percentage of change from baseline
Interval 176.0 to 272.32
|
31.42 percentage of change from baseline
Interval -16.74 to 79.57
|
6.18 percentage of change from baseline
Interval -28.37 to 40.73
|
106.76 percentage of change from baseline
Interval 58.6 to 154.91
|
334.52 percentage of change from baseline
Interval 286.36 to 382.68
|
|
Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)
Day 85
|
9.28 percentage of change from baseline
Interval -22.36 to 40.93
|
25.77 percentage of change from baseline
Interval -5.88 to 57.42
|
14.27 percentage of change from baseline
Interval -17.38 to 45.92
|
24.07 percentage of change from baseline
Interval -7.58 to 55.72
|
33.84 percentage of change from baseline
Interval 2.2 to 65.49
|
19.24 percentage of change from baseline
Interval -12.41 to 50.89
|
9.86 percentage of change from baseline
Interval -12.52 to 32.24
|
33.59 percentage of change from baseline
Interval 1.95 to 65.24
|
23.98 percentage of change from baseline
Interval -7.67 to 55.62
|
SECONDARY outcome
Timeframe: Day 1: Predose, Day 29 anytime, Day 85 anytimePopulation: All participants who received study drug and had evaluable results at the analyzed time points.
A validated assay designed to perform in the presence of LY2541546 was used for to assess development of antibodies.
Outcome measures
| Measure |
7.5 mg LY2541546 - IV
n=6 Participants
Single dose of 7.5 mg LY2541546 administered intravenously (IV)
|
25 mg LY2541546 - IV
n=6 Participants
Single dose of 25 mg LY2541546 administered IV
|
75 mg LY2541546 - IV
n=6 Participants
Single dose of 75 mg LY2541546 administered IV
|
225 mg LY2541546 - IV
n=6 Participants
Single dose of 225 mg LY2541546 administered IV
|
750 mg LY2541546 - IV
n=6 Participants
Single dose of 750 mg LY2541546 administered IV
|
150 mg LY2541546 - SC
n=6 Participants
Single dose of 150 mg LY2541546 administered subcutaneous (SC)
|
Placebo
n=12 Participants
Single dose of placebo administered IV or SC
|
225 mg LY2541546 - IV, OL
n=6 Participants
Single dose of 225 mg LY2541546 administered IV, open label (OL)
|
750 mg LY2541546 - IV, OL
n=6 Participants
Single dose of 750 mg LY2541546 administered IV, OL
|
|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies
Day 29
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies
Day 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies
Day 85
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
7.5 mg LY2541546 - IV
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
25 mg LY2541546 - IV
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
75 mg LY2541546 - IV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
225 mg LY2541546 - IV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
750 mg LY2541546 - IV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
150 mg LY2541546 - SC
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
225 mg LY2541546 - IV, OL
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
750 mg LY2541546 - IV, OL
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
7.5 mg LY2541546 - IV
n=6 participants at risk
Single dose of 7.5 mg LY2541546 administered intravenously (IV)
|
25 mg LY2541546 - IV
n=6 participants at risk
Single dose of 25 mg LY2541546 administered IV
|
75 mg LY2541546 - IV
n=6 participants at risk
Single dose of 75 mg LY2541546 administered IV
|
225 mg LY2541546 - IV
n=6 participants at risk
Single dose of 225 mg LY2541546 administered IV
|
750 mg LY2541546 - IV
n=6 participants at risk
Single dose of 750 mg LY2541546 administered IV
|
150 mg LY2541546 - SC
n=6 participants at risk
Single dose of 150 mg LY2541546 administered subcutaneous (SC)
|
Placebo
n=12 participants at risk
Single dose of placebo administered IV or SC
|
225 mg LY2541546 - IV, OL
n=6 participants at risk
Single dose of 225 mg LY2541546 administered IV, open label (OL)
|
750 mg LY2541546 - IV, OL
n=6 participants at risk
Single dose of 750 mg LY2541546 administered IV, OL
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
16.7%
1/6 • Number of events 3
|
0.00%
0/6
|
|
Cardiac disorders
Conduction disorder
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Visual disturbance
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/12
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Application site irritation
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Catheter site erythema
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Catheter site pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Nodule
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Pyrexia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Vessel puncture site haematoma
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Myringitis
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Otitis media
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1
|
50.0%
3/6 • Number of events 5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Viral infection
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
50.0%
3/6 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Joint sprain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
2/12 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 3
|
50.0%
3/6 • Number of events 4
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Psychiatric disorders
Stress
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Renal and urinary disorders
Urinary incontinence
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
2/12 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hot flush
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
|
Vascular disorders
Hypertension
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60