Trial Outcomes & Findings for Study of LY3016859 in Participants With Diabetic Nephropathy (NCT NCT01774981)
NCT ID: NCT01774981
Last Updated: 2019-09-19
Results Overview
Proteinuria is defined as the ratio of protein to creatinine.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline, 16 Weeks
Results posted on
2019-09-19
Participant Flow
Participant milestones
| Measure |
Placebo (Part A)
Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
|
10 mg LY3016859 (Part A)
Part A: 10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
|
100 mg LY3016859 (Part A)
Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
|
750 mg LY3016859 (Part A)
Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
|
Placebo (Part B)
Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
50 mg LY3016859 (Part B)
Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
250 mg LY3016859 (Part B)
Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
750 mg LY3016859 (Part B)
Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
4
|
4
|
6
|
14
|
13
|
12
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
3
|
4
|
4
|
4
|
6
|
14
|
13
|
12
|
|
Overall Study
COMPLETED
|
3
|
4
|
4
|
4
|
5
|
13
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo (Part A)
Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
|
10 mg LY3016859 (Part A)
Part A: 10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
|
100 mg LY3016859 (Part A)
Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
|
750 mg LY3016859 (Part A)
Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
|
Placebo (Part B)
Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
50 mg LY3016859 (Part B)
Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
250 mg LY3016859 (Part B)
Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
750 mg LY3016859 (Part B)
Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study of LY3016859 in Participants With Diabetic Nephropathy
Baseline characteristics by cohort
| Measure |
Placebo (Part A)
n=3 Participants
Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
|
10 mg LY3016859 (Part A)
n=4 Participants
Part A: 10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
|
100 mg LY3016859 (Part A)
n=4 Participants
Part A:100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
|
750 mg LY3016859 (Part A)
n=4 Participants
Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
|
Placebo (Part B)
n=6 Participants
Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
50 mg LY3016859 (Part B)
n=14 Participants
Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
250 mg LY3016859 (Part B)
n=13 Participants
Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
750 mg LY3016859 (Part B)
n=12 Participants
Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
57 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
56 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
62 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
55 years
STANDARD_DEVIATION 5.0 • n=21 Participants
|
63 years
STANDARD_DEVIATION 8.3 • n=10 Participants
|
55 years
STANDARD_DEVIATION 12.7 • n=115 Participants
|
59 years
STANDARD_DEVIATION 9.5 • n=24 Participants
|
58.5 years
STANDARD_DEVIATION 9.6 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
28 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
32 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
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
50 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
|
|
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
|
|
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
|
|
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
|
|
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
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
12 Participants
n=24 Participants
|
58 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
|
|
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
|
|
Region of Enrollment
United States
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
9 Participants
n=24 Participants
|
37 Participants
n=42 Participants
|
|
Region of Enrollment
Bulgaria
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants who received at least one dose of study drug in Part B with a baseline measurement and at least one post-baseline measurement.
Proteinuria is defined as the ratio of protein to creatinine.
Outcome measures
| Measure |
Placebo (Part B)
n=6 Participants
Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
50 mg LY3016859 (Part B)
n=9 Participants
Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
250 mg LY3016859 (Part B)
n=9 Participants
Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
750 mg LY3016859 (Part B)
n=11 Participants
Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
Placebo (Part B)
Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
50 mg LY3016859 (Part B)
Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
250 mg LY3016859 (Part B)
Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
750 mg LY3016859 (Part B)
Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
|---|---|---|---|---|---|---|---|---|
|
Part B:Change From Baseline in Proteinuria
|
1.5 grams per 12 hour (g/12 hour)
Standard Deviation 2.04
|
-0.4 grams per 12 hour (g/12 hour)
Standard Deviation 1.60
|
0.1 grams per 12 hour (g/12 hour)
Standard Deviation 1.21
|
0.7 grams per 12 hour (g/12 hour)
Standard Deviation 2.23
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 32 WeeksPopulation: All randomized participants who received at least one dose of study drug.
Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Placebo (Part B)
n=3 Participants
Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
50 mg LY3016859 (Part B)
n=4 Participants
Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
250 mg LY3016859 (Part B)
n=4 Participants
Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
750 mg LY3016859 (Part B)
n=4 Participants
Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
Placebo (Part B)
n=6 Participants
Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
50 mg LY3016859 (Part B)
n=14 Participants
Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
250 mg LY3016859 (Part B)
n=13 Participants
Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
750 mg LY3016859 (Part B)
n=12 Participants
Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
|---|---|---|---|---|---|---|---|---|
|
Part A and Part B: Number of Participants With One or More Treatment Emergent Adverse Events (AEs) or Any Serious AEs
|
1 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
13 Participants
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline, 19 WeeksPopulation: All randomized participants who received at least one dose of study drug and were in Part B with a baseline measurement and at least one post-baseline measurement.
Proteinuria is defined as the ratio of protein to creatinine.
Outcome measures
| Measure |
Placebo (Part B)
n=5 Participants
Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
50 mg LY3016859 (Part B)
n=11 Participants
Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
250 mg LY3016859 (Part B)
n=12 Participants
Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
750 mg LY3016859 (Part B)
n=11 Participants
Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
Placebo (Part B)
Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
50 mg LY3016859 (Part B)
Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
250 mg LY3016859 (Part B)
Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
750 mg LY3016859 (Part B)
Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Proteinuria Over Time
|
19.3 mg/dl of protein/ by mg/dl of creatinine
Standard Deviation 154.66
|
-17.3 mg/dl of protein/ by mg/dl of creatinine
Standard Deviation 81.95
|
-2.4 mg/dl of protein/ by mg/dl of creatinine
Standard Deviation 88.01
|
48.6 mg/dl of protein/ by mg/dl of creatinine
Standard Deviation 130.13
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 19 WeeksPopulation: All randomized participants who received at least one dose of study drug and were in Part B with a baseline measurement and at least one post-baseline measurement.
Albuminuria is defined as the ratio of albumin to creatinine.
Outcome measures
| Measure |
Placebo (Part B)
n=5 Participants
Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
50 mg LY3016859 (Part B)
n=11 Participants
Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
250 mg LY3016859 (Part B)
n=12 Participants
Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
750 mg LY3016859 (Part B)
n=11 Participants
Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
Placebo (Part B)
Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
50 mg LY3016859 (Part B)
Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
250 mg LY3016859 (Part B)
Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
750 mg LY3016859 (Part B)
Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Albuminuria Over Time
|
8.6 mg/dl of albumin/ by mg/dl of creatinine
Standard Deviation 100.57
|
-15.6 mg/dl of albumin/ by mg/dl of creatinine
Standard Deviation 64.27
|
-8.1 mg/dl of albumin/ by mg/dl of creatinine
Standard Deviation 50.19
|
36.7 mg/dl of albumin/ by mg/dl of creatinine
Standard Deviation 93.49
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo (Part A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
10 mg LY3016859 (Part A)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
100 mg LY3016859 (Part A)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
750 mg LY3016859 (Part A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo (Part B)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
50 mg LY3016859 (Part B)
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
250 mg LY3016859 (Part B)
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
750 mg LY3016859 (Part B)
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Part A)
n=3 participants at risk
Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
|
10 mg LY3016859 (Part A)
n=4 participants at risk
Part A:10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
|
100 mg LY3016859 (Part A)
n=4 participants at risk
Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
|
750 mg LY3016859 (Part A)
n=4 participants at risk
Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
|
Placebo (Part B)
n=6 participants at risk
Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
50 mg LY3016859 (Part B)
n=14 participants at risk
Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
250 mg LY3016859 (Part B)
n=13 participants at risk
Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
750 mg LY3016859 (Part B)
n=12 participants at risk
Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
|---|---|---|---|---|---|---|---|---|
|
Surgical and medical procedures
Femoropopliteal artery bypass
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Cardiac disorders
Anginal pain
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Cardiac disorders
Atrial fibrillation aggravated
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Gastrointestinal disorders
Phytobezoar
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Sudden death
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Hepatobiliary disorders
Acalculous cholecystitis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Chronic lower extremity cellulitis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Peritonitis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
Other adverse events
| Measure |
Placebo (Part A)
n=3 participants at risk
Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
|
10 mg LY3016859 (Part A)
n=4 participants at risk
Part A:10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
|
100 mg LY3016859 (Part A)
n=4 participants at risk
Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
|
750 mg LY3016859 (Part A)
n=4 participants at risk
Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
|
Placebo (Part B)
n=6 participants at risk
Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
50 mg LY3016859 (Part B)
n=14 participants at risk
Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
250 mg LY3016859 (Part B)
n=13 participants at risk
Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
750 mg LY3016859 (Part B)
n=12 participants at risk
Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Anemia aggravated
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Cardiac disorders
Heart pounding
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Cloudy vision
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Eye disorders
Glaucoma
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Right cataract
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Eye disorders
Tearing decreased
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal cramps
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal fullness
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
|
Gastrointestinal disorders
Distress gastrointestinal
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dry heaves
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
15.4%
2/13 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 2
|
0.00%
0/12
|
|
General disorders
Application site pain
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
General disorders
Chest pain
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Coldness general
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
General disorders
Edema aggravated
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
21.4%
3/14 • Number of events 3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Edema generalized
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Fatigue aggravated
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Fever
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
General disorders
General body pain
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Swelling of legs
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Hepatobiliary disorders
Portal vein phlebitis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Immune system disorders
Hay fever
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Infections and infestations
Alpha hemolytic streptococcal infection
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Axillary abscess
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Bacterial infection due to unspecified staphylococcus
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Cellulitis of hand
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Infections and infestations
Cellulitis of leg
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Cold
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Infections and infestations
Common cold
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Infections and infestations
Dental abscess
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Flu
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Head cold
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Infections and infestations
Kidney infection
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Infections and infestations
Leg infection
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Infections and infestations
Tooth infection
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
14.3%
2/14 • Number of events 2
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
14.3%
2/14 • Number of events 2
|
0.00%
0/13
|
0.00%
0/12
|
|
Infections and infestations
Urinary tract yeast infection
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Infections and infestations
Viral infection
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
7.1%
1/14 • Number of events 2
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Viral labyrinthitis
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Infections and infestations
Viral syndrome
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Abrasions
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Ankle sprain
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
First degree burns
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Injury, poisoning and procedural complications
Flea bite
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hematoma traumatic
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Lower limb wound
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Spider bite
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Sprained ankle
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
14.3%
2/14 • Number of events 2
|
0.00%
0/13
|
0.00%
0/12
|
|
Investigations
Bicarbonate decreased serum
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Blood glucose increased
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 2
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Investigations
Blood pressure increased
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Investigations
Cholesterol levels raised
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Investigations
Ecg abnormal
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Investigations
Fasting blood glucose abnormal
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Investigations
Increased intraocular pressure
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Platelets decreased
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Potassium abnormal
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Investigations
Potassium increased
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Investigations
Renal function test abnormal
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Investigations
Thyroid function test abnormal
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 2
|
0.00%
0/13
|
0.00%
0/12
|
|
Investigations
Uric acid level increased
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Investigations
Weight gain
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Appetite lost
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Fasting hyperglycemia
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Gout aggravated
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Gout flare
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
16.7%
2/12 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 2
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypoglycemia aggravated
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolic acidosis worsened
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Volume depletion
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Volume overload
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
14.3%
2/14 • Number of events 2
|
0.00%
0/13
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
14.3%
2/14 • Number of events 2
|
0.00%
0/13
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Pain in thumb
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid nodule
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
25.0%
1/4 • Number of events 2
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
7.1%
1/14 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Headache aggravated
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Numbness
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Sciatica aggravated
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Psychiatric disorders
Depression worsened
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Psychiatric disorders
Difficulty sleeping
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Renal and urinary disorders
Diuresis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Renal and urinary disorders
Kidney function abnormal
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Cough nonproductive
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal cyst
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Nosebleed
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Supine dyspnea
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
15.4%
2/13 • Number of events 2
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Generalized itching
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
16.7%
2/12 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Localised rash
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Localized erythema
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Papular rash
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Skin inflammation
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Skin peeling
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Surgical and medical procedures
Mohs micrographic surgery
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Surgical and medical procedures
Squamous cell carcinoma excision
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
7.7%
1/13 • Number of events 2
|
0.00%
0/12
|
|
Vascular disorders
Blood pressure high
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Vascular disorders
Flushing of face
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Vascular disorders
Hematoma
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Vascular disorders
Hypertension exacerbated
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
|
Vascular disorders
Hypertension worsened
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
14.3%
2/14 • Number of events 2
|
0.00%
0/13
|
0.00%
0/12
|
|
General disorders
Infusion Site Erythema
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Nervous system disorders
Crawling Sensation
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Nervous system disorders
Numbness in Feet
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Runny Nose
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
|
Nervous system disorders
Body Numbness
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
0.00%
0/12
|
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