Trial Outcomes & Findings for A Safety Study of Mirikizumab (LY3074828) (NCT NCT01947933)
NCT ID: NCT01947933
Last Updated: 2024-07-25
Results Overview
This outcome has the list of adverse events which are related to the study drug. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
45 participants
Primary outcome timeframe
Baseline through Week 12
Results posted on
2024-07-25
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo, single dose, administered intravenously (IV)
|
5 mg LY3074828
5 milligram (mg) LY3074828, single dose, administered IV
|
20 mg LY3074828
20 mg LY3074828, single dose, administered IV
|
60 mg LY3074828
60 mg LY3074828, single dose, administered IV
|
120 mg LY3074828
120 mg LY3074828, single dose, administered IV
|
120 mg LY3074828 SC
120 mg LY3074828, single dose, administered subcutaneously (SC)
|
200 mg LY3074828
200 mg LY3074828, single dose, administered IV
|
350 mg LY3074828
350 mg LY3074828, single dose, administered IV
|
600 mg LY3074828
600 mg LY3074828, single dose, administered IV
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
5
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
7
|
3
|
4
|
5
|
5
|
5
|
5
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo, single dose, administered intravenously (IV)
|
5 mg LY3074828
5 milligram (mg) LY3074828, single dose, administered IV
|
20 mg LY3074828
20 mg LY3074828, single dose, administered IV
|
60 mg LY3074828
60 mg LY3074828, single dose, administered IV
|
120 mg LY3074828
120 mg LY3074828, single dose, administered IV
|
120 mg LY3074828 SC
120 mg LY3074828, single dose, administered subcutaneously (SC)
|
200 mg LY3074828
200 mg LY3074828, single dose, administered IV
|
350 mg LY3074828
350 mg LY3074828, single dose, administered IV
|
600 mg LY3074828
600 mg LY3074828, single dose, administered IV
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Safety Study of Mirikizumab (LY3074828)
Baseline characteristics by cohort
| Measure |
Placebo
n=7 Participants
Placebo administered intravenously (IV)
|
5 mg LY3074828
n=3 Participants
5 mg LY3074828 administered IV
|
20 mg LY3074828
n=5 Participants
20 mg LY3074828 administered IV
|
60 mg LY3074828
n=5 Participants
60 mg LY3074828 administered IV
|
120 mg LY3074828
n=5 Participants
120 mg LY3074828 administered IV
|
120 mg LY3074828 SC
n=5 Participants
120 mg LY3074828 administered subcutaneously (SC)
|
200 mg LY3074828
n=5 Participants
200 mg LY3074828 administered IV
|
350 mg LY3074828
n=5 Participants
350 mg LY3074828 administered IV
|
600 mg LY3074828
n=5 Participants
600 mg LY3074828 administered IV
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.7 Years
STANDARD_DEVIATION 13.39 • n=5 Participants
|
51.0 Years
STANDARD_DEVIATION 13.08 • n=7 Participants
|
43.4 Years
STANDARD_DEVIATION 13.32 • n=5 Participants
|
44.0 Years
STANDARD_DEVIATION 9.14 • n=4 Participants
|
43.8 Years
STANDARD_DEVIATION 13.33 • n=21 Participants
|
37.2 Years
STANDARD_DEVIATION 13.33 • n=10 Participants
|
53.2 Years
STANDARD_DEVIATION 14.55 • n=115 Participants
|
37.4 Years
STANDARD_DEVIATION 11.37 • n=24 Participants
|
42.2 Years
STANDARD_DEVIATION 10.57 • n=42 Participants
|
43.8 Years
STANDARD_DEVIATION 12.37 • n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
44 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
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=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
45 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
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=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
Canada
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
45 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 12Population: Safety Population: all randomized participants who received any amount of study drug.
This outcome has the list of adverse events which are related to the study drug. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo, single dose, administered intravenously (IV)
|
5 mg LY3074828
n=3 Participants
5 mg LY3074828, single dose, administered IV
|
20 mg LY3074828
n=5 Participants
20 mg LY3074828, single dose, administered IV
|
60 mg LY3074828
n=5 Participants
60 mg LY3074828, single dose, administered IV
|
120 mg LY3074828
n=5 Participants
120 mg LY3074828, single dose, administered IV
|
120 mg LY3074828 SC
n=5 Participants
120 mg LY3074828, single dose, administered subcutaneously (SC)
|
200 mg LY3074828
n=5 Participants
200 mg LY3074828, single dose, administered IV
|
350 mg LY3074828
n=5 Participants
350 mg LY3074828, single dose, administered IV
|
600 mg LY3074828
n=5 Participants
600 mg LY3074828, single dose, administered IV
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Adverse Event(s) (AEs) Considered by the Investigator to Be Related to Study Drug Administration
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: IV Arms: Day 1 Predose, Postdose (End of Infusion, 2, 6 and 24h), Days 4, 8, 15, 22, 29, 43, 57, 71, and 85. SC Arm: Day 1 Predose, Postdose (6 and 24h), Days 4, 8, 11, 15, 22, 29, 43, 57, 71, and 85Population: All randomized participants who received any amount of study drug and had evaluable PK data.
Outcome measures
| Measure |
Placebo
n=2 Participants
Placebo, single dose, administered intravenously (IV)
|
5 mg LY3074828
n=5 Participants
5 mg LY3074828, single dose, administered IV
|
20 mg LY3074828
n=5 Participants
20 mg LY3074828, single dose, administered IV
|
60 mg LY3074828
n=5 Participants
60 mg LY3074828, single dose, administered IV
|
120 mg LY3074828
n=5 Participants
120 mg LY3074828, single dose, administered IV
|
120 mg LY3074828 SC
n=5 Participants
120 mg LY3074828, single dose, administered subcutaneously (SC)
|
200 mg LY3074828
n=5 Participants
200 mg LY3074828, single dose, administered IV
|
350 mg LY3074828
n=5 Participants
350 mg LY3074828, single dose, administered IV
|
600 mg LY3074828
600 mg LY3074828, single dose, administered IV
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828
|
NA μg•day/mL (microgram•day/milliliters)
Geometric Coefficient of Variation NA
One participant not included in calculation of summary statistics. Geometric Mean and %CV not calculated for 2 participants. Values = Min 6.72, Max 8.40
|
33.6 μg•day/mL (microgram•day/milliliters)
Geometric Coefficient of Variation 17
|
117 μg•day/mL (microgram•day/milliliters)
Geometric Coefficient of Variation 15
|
287 μg•day/mL (microgram•day/milliliters)
Geometric Coefficient of Variation 29
|
114 μg•day/mL (microgram•day/milliliters)
Geometric Coefficient of Variation 49
|
366 μg•day/mL (microgram•day/milliliters)
Geometric Coefficient of Variation 12
|
556 μg•day/mL (microgram•day/milliliters)
Geometric Coefficient of Variation 25
|
1360 μg•day/mL (microgram•day/milliliters)
Geometric Coefficient of Variation 23
|
—
|
SECONDARY outcome
Timeframe: IV Arms: Day 1 Predose, Postdose (End of Infusion, 2, 6 and 24h), Days 4, 8, 15, 22, 29, 43, 57, 71, and 85. SC Arm: Day 1 Predose, Postdose (6 and 24h), Days 4, 8, 11, 15, 22, 29, 43, 57, 71, and 85Population: All randomized participants who received any amount of study drug and had evaluable PK data.
Outcome measures
| Measure |
Placebo
n=3 Participants
Placebo, single dose, administered intravenously (IV)
|
5 mg LY3074828
n=5 Participants
5 mg LY3074828, single dose, administered IV
|
20 mg LY3074828
n=5 Participants
20 mg LY3074828, single dose, administered IV
|
60 mg LY3074828
n=5 Participants
60 mg LY3074828, single dose, administered IV
|
120 mg LY3074828
n=5 Participants
120 mg LY3074828, single dose, administered IV
|
120 mg LY3074828 SC
n=5 Participants
120 mg LY3074828, single dose, administered subcutaneously (SC)
|
200 mg LY3074828
n=5 Participants
200 mg LY3074828, single dose, administered IV
|
350 mg LY3074828
n=5 Participants
350 mg LY3074828, single dose, administered IV
|
600 mg LY3074828
600 mg LY3074828, single dose, administered IV
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828
|
1.60 μg/mL (microgram/milliliter)
Geometric Coefficient of Variation 22
|
5.34 μg/mL (microgram/milliliter)
Geometric Coefficient of Variation 6
|
20.6 μg/mL (microgram/milliliter)
Geometric Coefficient of Variation 29
|
41.1 μg/mL (microgram/milliliter)
Geometric Coefficient of Variation 15
|
7.28 μg/mL (microgram/milliliter)
Geometric Coefficient of Variation 23
|
68.8 μg/mL (microgram/milliliter)
Geometric Coefficient of Variation 19
|
91.8 μg/mL (microgram/milliliter)
Geometric Coefficient of Variation 6
|
220 μg/mL (microgram/milliliter)
Geometric Coefficient of Variation 24
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
5 mg LY3074828
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
20 mg LY3074828
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
60 mg LY3074828
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
120 mg LY3074828
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
120 mg LY3074828 SC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
200 mg LY3074828
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
350 mg LY3074828
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
600 mg LY3074828
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=7 participants at risk
Placebo, single dose, administered intravenously (IV)
|
5 mg LY3074828
n=3 participants at risk
5 mg LY3074828, single dose, administered IV
|
20 mg LY3074828
n=5 participants at risk
20 mg LY3074828, single dose, administered IV
|
60 mg LY3074828
n=5 participants at risk
60 mg LY3074828, single dose, administered IV
|
120 mg LY3074828
n=5 participants at risk
120 mg LY3074828, single dose, administered IV
|
120 mg LY3074828 SC
n=5 participants at risk
120 mg LY3074828, single dose, administered subcutaneously (SC)
|
200 mg LY3074828
n=5 participants at risk
200 mg LY3074828, single dose, administered IV
|
350 mg LY3074828
n=5 participants at risk
350 mg LY3074828, single dose, administered IV
|
600 mg LY3074828
n=5 participants at risk
600 mg LY3074828, single dose, administered IV
|
|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/7
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
40.0%
2/5 • Number of events 3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7
|
66.7%
2/3 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7
|
0.00%
0/3
|
40.0%
2/5 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Injection site pain
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
60.0%
3/5 • Number of events 5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Oedema peripheral
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/7
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Infections and infestations
Bronchitis
|
0.00%
0/7
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Infections and infestations
Laryngitis
|
0.00%
0/7
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Infections and infestations
Nasopharyngitis
|
42.9%
3/7 • Number of events 3
|
0.00%
0/3
|
80.0%
4/5 • Number of events 4
|
80.0%
4/5 • Number of events 4
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Otitis externa
|
0.00%
0/7
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
40.0%
2/5 • Number of events 2
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
40.0%
2/5 • Number of events 2
|
0.00%
0/5
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7
|
33.3%
1/3 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7
|
33.3%
1/3 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Nervous system disorders
Dizziness exertional
|
0.00%
0/7
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Number of events 2
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
20.0%
1/5 • Number of events 2
|
60.0%
3/5 • Number of events 3
|
0.00%
0/5
|
60.0%
3/5 • Number of events 3
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
50.0%
1/2 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Number of events 2
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Vascular disorders
Hypertension
|
0.00%
0/7
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
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