Trial Outcomes & Findings for A Study in Rheumatoid Arthritis (NCT NCT01253265)
NCT ID: NCT01253265
Last Updated: 2016-05-26
Results Overview
Clinically significant events were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Baseline up to 26 weeks
Results posted on
2016-05-26
Participant Flow
Participant milestones
| Measure |
30 Milligram (mg) LY2439821
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
80 mg LY2439821
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
180 mg LY2439821
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
120 mg LY2439821
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
|
Placebo
Placebo is administered subcutaneously in the same manner as active drug in each dose group
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
5
|
6
|
6
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
30 Milligram (mg) LY2439821
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
80 mg LY2439821
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
180 mg LY2439821
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
120 mg LY2439821
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
|
Placebo
Placebo is administered subcutaneously in the same manner as active drug in each dose group
|
|---|---|---|---|---|---|
|
Overall Study
Met Predefined Discontinuation Criteria
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study in Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
30 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
80 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
180 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
120 mg LY2439821
n=6 Participants
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
|
Placebo
n=8 Participants
Placebo is administered subcutaneously in the same manner as active drug in each dose group
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.0 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 14.0 • n=4 Participants
|
60.1 years
STANDARD_DEVIATION 7.7 • n=21 Participants
|
57.0 years
STANDARD_DEVIATION 11.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
8 participants
n=21 Participants
|
32 participants
n=8 Participants
|
|
Region of Enrollment
Japan
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
8 participants
n=21 Participants
|
32 participants
n=8 Participants
|
|
C-Reactive Protein (CRP)
|
7.950 milligrams per liter (mg/L)
n=5 Participants
|
11.750 milligrams per liter (mg/L)
n=7 Participants
|
3.500 milligrams per liter (mg/L)
n=5 Participants
|
31.000 milligrams per liter (mg/L)
n=4 Participants
|
5.650 milligrams per liter (mg/L)
n=21 Participants
|
9.700 milligrams per liter (mg/L)
n=8 Participants
|
|
Erythrocyte Sedimentation Rate (ESR)
|
28.0 millimeters per hour (mm/h)
n=5 Participants
|
53.5 millimeters per hour (mm/h)
n=7 Participants
|
26.0 millimeters per hour (mm/h)
n=5 Participants
|
42.5 millimeters per hour (mm/h)
n=4 Participants
|
25.5 millimeters per hour (mm/h)
n=21 Participants
|
29.5 millimeters per hour (mm/h)
n=8 Participants
|
|
Neutrophils
|
6.763 10^9 cells per liter (GI/L)
n=5 Participants
|
4.293 10^9 cells per liter (GI/L)
n=7 Participants
|
3.857 10^9 cells per liter (GI/L)
n=5 Participants
|
6.056 10^9 cells per liter (GI/L)
n=4 Participants
|
6.757 10^9 cells per liter (GI/L)
n=21 Participants
|
5.261 10^9 cells per liter (GI/L)
n=8 Participants
|
|
Lymphocytes
|
0.993 10^9 cells per liter (GI/L)
n=5 Participants
|
1.156 10^9 cells per liter (GI/L)
n=7 Participants
|
1.187 10^9 cells per liter (GI/L)
n=5 Participants
|
1.379 10^9 cells per liter (GI/L)
n=4 Participants
|
1.295 10^9 cells per liter (GI/L)
n=21 Participants
|
1.275 10^9 cells per liter (GI/L)
n=8 Participants
|
|
Duration of Rheumatoid Arthritis (RA)
|
10.9 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
7.9 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
6.8 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
5.6 years
STANDARD_DEVIATION 4.1 • n=4 Participants
|
3.6 years
STANDARD_DEVIATION 3.2 • n=21 Participants
|
6.8 years
STANDARD_DEVIATION 8.5 • n=8 Participants
|
|
Weekly dose of Methotrexate (MTX)
|
8.33 milligrams per week (mg/wk)
STANDARD_DEVIATION 0.82 • n=5 Participants
|
8.33 milligrams per week (mg/wk)
STANDARD_DEVIATION 0.82 • n=7 Participants
|
8.00 milligrams per week (mg/wk)
STANDARD_DEVIATION 0.00 • n=5 Participants
|
9.00 milligrams per week (mg/wk)
STANDARD_DEVIATION 1.10 • n=4 Participants
|
9.06 milligrams per week (mg/wk)
STANDARD_DEVIATION 1.66 • n=21 Participants
|
8.58 milligrams per week (mg/wk)
STANDARD_DEVIATION 1.10 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 26 weeksPopulation: All randomized participants.
Clinically significant events were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.
Outcome measures
| Measure |
30 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
80 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
180 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
120 mg LY2439821
n=6 Participants
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
|
Placebo
n=8 Participants
Placebo is administered subcutaneously in the same manner as active drug in each dose group
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Effects
Serious Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Effects
Other Adverse Events
|
4 participants
|
5 participants
|
3 participants
|
3 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: All randomized participants.
C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter.
Outcome measures
| Measure |
30 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
80 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
180 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
120 mg LY2439821
n=6 Participants
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
|
Placebo
n=8 Participants
Placebo is administered subcutaneously in the same manner as active drug in each dose group
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline to 16 Week Endpoint in C-Reactive Protein
|
-88.75 percentage change in C-Reactive Protein
Interval -98.6 to -66.7
|
-73.81 percentage change in C-Reactive Protein
Interval -98.8 to 180.0
|
-17.04 percentage change in C-Reactive Protein
Interval -48.4 to 150.0
|
-95.47 percentage change in C-Reactive Protein
Interval -99.3 to 100.0
|
-8.07 percentage change in C-Reactive Protein
Interval -82.8 to 186.2
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: All randomized participants.
Erythrocyte Sedimentation Rate (ESR) is a disease related biomarker and measured in millimeters per hour (mm/h).
Outcome measures
| Measure |
30 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
80 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
180 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
120 mg LY2439821
n=6 Participants
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
|
Placebo
n=8 Participants
Placebo is administered subcutaneously in the same manner as active drug in each dose group
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline to 16 Week Endpoint in Erythrocyte Sedimentation Rate (ESR)
|
-44.50 percentage change in ESR
Interval -80.0 to -16.7
|
-35.05 percentage change in ESR
Interval -76.1 to 13.3
|
-3.75 percentage change in ESR
Interval -37.9 to 100.0
|
-73.08 percentage change in ESR
Interval -92.7 to -5.6
|
-12.62 percentage change in ESR
Interval -54.5 to 137.5
|
SECONDARY outcome
Timeframe: Baseline, 26 weeksPopulation: All randomized participants.
Outcome measures
| Measure |
30 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
80 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
180 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
120 mg LY2439821
n=6 Participants
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
|
Placebo
n=8 Participants
Placebo is administered subcutaneously in the same manner as active drug in each dose group
|
|---|---|---|---|---|---|
|
Change From Baseline to 26 Week Endpoint in Neutrophil Counts
|
0.681 10^9 cells per liter (GI/L)
Interval -5.77 to 5.84
|
-0.559 10^9 cells per liter (GI/L)
Interval -2.62 to 5.62
|
-0.170 10^9 cells per liter (GI/L)
Interval -0.87 to 2.72
|
-2.677 10^9 cells per liter (GI/L)
Interval -2.87 to -0.7
|
-0.641 10^9 cells per liter (GI/L)
Interval -2.94 to 2.29
|
SECONDARY outcome
Timeframe: Baseline, 26 weeksPopulation: All randomized participants.
Outcome measures
| Measure |
30 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
80 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
180 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
120 mg LY2439821
n=6 Participants
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
|
Placebo
n=8 Participants
Placebo is administered subcutaneously in the same manner as active drug in each dose group
|
|---|---|---|---|---|---|
|
Change From Baseline to 26 Week Endpoint in Lymphocyte Counts
|
0.189 10^9 cells per liter (GI/L)
Interval -1.19 to 1.23
|
-0.011 10^9 cells per liter (GI/L)
Interval -0.54 to 1.25
|
-0.184 10^9 cells per liter (GI/L)
Interval -0.37 to 0.09
|
0.138 10^9 cells per liter (GI/L)
Interval -0.15 to 0.65
|
0.085 10^9 cells per liter (GI/L)
Interval -0.56 to 0.24
|
SECONDARY outcome
Timeframe: Week 10 pre-dose up to 2 weeks post-dose (Week 12)Population: All randomized participants with analyzable pharmacokinetic data.
AUCτ,ss= area under the concentration versus time curve (τ) at steady state (ss)
Outcome measures
| Measure |
30 mg LY2439821
n=5 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
80 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
180 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
120 mg LY2439821
n=6 Participants
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
|
Placebo
Placebo is administered subcutaneously in the same manner as active drug in each dose group
|
|---|---|---|---|---|---|
|
Pharmacokinetics - Area Under the Concentration-time Curve (AUC) at Steady State (ss)
|
77.2 micrograms•day per milliliter(μg•day/mL)
Geometric Coefficient of Variation 26
|
151 micrograms•day per milliliter(μg•day/mL)
Geometric Coefficient of Variation 44
|
437 micrograms•day per milliliter(μg•day/mL)
Geometric Coefficient of Variation 42
|
208 micrograms•day per milliliter(μg•day/mL)
Geometric Coefficient of Variation 48
|
—
|
SECONDARY outcome
Timeframe: Week 10 pre-dose up to 2 weeks post-dose (Week 12)Population: All randomized participants with analyzable pharmacokinetic data.
Cmax,ss = maximum observed drug concentration (Cmax) at steady state (ss)
Outcome measures
| Measure |
30 mg LY2439821
n=5 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
80 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
180 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
120 mg LY2439821
n=6 Participants
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
|
Placebo
Placebo is administered subcutaneously in the same manner as active drug in each dose group
|
|---|---|---|---|---|---|
|
Pharmacokinetics - Maximum Plasma Drug Concentration (Cmax) at Steady State (ss)
|
7.05 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 26
|
13.5 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 43
|
39.3 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 42
|
33.1 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 56
|
—
|
SECONDARY outcome
Timeframe: Week 10 pre-dose up to 2 weeks post-dose (Week 12)Population: All randomized participants with analyzable pharmacokinetic data.
tmax,ss = time of maximum observed drug concentration (tmax) at steady state (ss)
Outcome measures
| Measure |
30 mg LY2439821
n=5 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
80 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
180 mg LY2439821
n=6 Participants
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
120 mg LY2439821
n=6 Participants
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
|
Placebo
Placebo is administered subcutaneously in the same manner as active drug in each dose group
|
|---|---|---|---|---|---|
|
Pharmacokinetics - Time of Maximum Observed Drug Concentration (Tmax) at Steady State (ss)
|
1.96 days
Interval 1.91 to 7.0
|
1.93 days
Interval 1.89 to 3.97
|
1.95 days
Interval 1.88 to 2.02
|
3.89 days
Interval 1.93 to 3.99
|
—
|
Adverse Events
30 mg LY2439821
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
80 mg LY2439821
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
180 mg LY2439821
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
120 mg LY2439821
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
30 mg LY2439821
n=6 participants at risk
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
80 mg LY2439821
n=6 participants at risk
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
180 mg LY2439821
n=6 participants at risk
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
|
120 mg LY2439821
n=6 participants at risk
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
|
Placebo
n=8 participants at risk
Placebo is administered subcutaneously in the same manner as active drug in each dose group
|
|---|---|---|---|---|---|
|
Eye disorders
Eyelid oedema
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
0.00%
0/8
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
General disorders
Administration site reaction
|
0.00%
0/6
|
16.7%
1/6 • Number of events 5
|
0.00%
0/6
|
16.7%
1/6 • Number of events 3
|
0.00%
0/8
|
|
General disorders
Feeling abnormal
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Injection site erythema
|
16.7%
1/6 • Number of events 3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
0.00%
0/8
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/8
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/8
|
|
Infections and infestations
Cystitis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/8
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
25.0%
2/8 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Bite
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Blood pressure decreased
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Blood pressure increased
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 3
|
0.00%
0/6
|
0.00%
0/8
|
|
Investigations
Blood urine present
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Protein urine present
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
37.5%
3/8 • Number of events 3
|
|
Nervous system disorders
Headache
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
Nervous system disorders
Migraine
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/8
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Surgical and medical procedures
Pain prophylaxis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 3
|
0.00%
0/8
|
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