Study of LY3016859 in Participants With Diabetic Nephropathy
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01774981
Collaborator
(none)
60
7
8
29
8.6
0.3
Study Details
Study Description
Brief Summary
The purpose of this two-part study is to investigate the safety, tolerability and efficacy of LY3016859 after multiple intravenous (IV) dosing's in participants with diabetic nephropathy (DN). Part A will be dose escalation for safety and tolerability and Part B will evaluate Proteinuria.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Study of the Safety and Efficacy of LY3016859 After Multiple Intravenous Dosing in Diabetic Nephropathy Patients
Study Start Date
:
Mar 1, 2013
Actual Primary Completion Date
:
Aug 1, 2015
Actual Study Completion Date
:
Aug 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo (Part A) Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4. |
Drug: Placebo
Administered IV
|
| Experimental: 10 mg LY3016859 (Part A) Part A: 10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. |
Drug: LY3016859
Administered IV
|
| Experimental: 100 mg LY3016859 (Part A) Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. |
Drug: LY3016859
Administered IV
|
| Experimental: 750 mg LY3016859 (Part A) Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. |
Drug: LY3016859
Administered IV
|
| Placebo Comparator: Placebo (Part B) Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. |
Drug: Placebo
Administered IV
|
| Experimental: 50 mg LY3016859 (Part B) Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. |
Drug: LY3016859
Administered IV
|
| Experimental: 250 mg LY3016859 (Part B) Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. |
Drug: LY3016859
Administered IV
|
| Experimental: 750 mg LY3016859 (Part B) Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. |
Drug: LY3016859
Administered IV
|
Outcome Measures
Primary Outcome Measures
- Part B:Change From Baseline in Proteinuria [Baseline, 16 Weeks]
Proteinuria is defined as the ratio of protein to creatinine.
- Part A and Part B: Number of Participants With One or More Treatment Emergent Adverse Events (AEs) or Any Serious AEs [Baseline up to 32 Weeks]
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.
Secondary Outcome Measures
- Part B: Change From Baseline in Proteinuria Over Time [Baseline, 19 Weeks]
Proteinuria is defined as the ratio of protein to creatinine.
- Part B: Change From Baseline in Albuminuria Over Time [Baseline, 19 Weeks]
Albuminuria is defined as the ratio of albumin to creatinine.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Stable diabetic kidney disease (DKD) while taking Standard of Care medication (SOC), as defined by:
-
Estimated glomerular filtration rate (eGFR) less than (<) 90 milliliter per minute per 1.73 square meter (ml/min/1.73m²) as determine utilizing the Modification of Diet in Renal Disease (MDRD) equation
-
Taking an angiotensin convertible enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) at a stable dose for greater than or equal to (≥) 2 months prior to randomization and agree to continue to take such throughout the duration of the study
-
Type 1 or Type 2 diabetes on a stable treatment regimen and adequately controlled in the opinion of the investigator
-
First morning protein-creatine ratio (PCR) at screening ≥400 milligrams per gram (mg/g) (Part B only)
-
Clinical chemistry labs within acceptable range for the participant population, as per investigator judgment
-
Men and women of non-childbearing potential as determined by medical history and physical examination
-
Non-vasectomized male participants must agree to use a medically accepted method of contraception with all sexual partners during the study and for 90 days following the final dosing. Medically accepted effective forms of contraception may include condoms with contraceptive foam or having partners use diaphragms with contraceptive jelly or cervical caps with contraceptive jelly
-
Female participants must be postmenopausal or surgically sterile to participate in this study. This is defined as females between age 45 to 75 years, inclusive, and either 12 months without a menstrual period [no follicle stimulating hormone (FSH) test required] or 6-12 months without a menstrual period and follicle stimulating hormone (FSH) greater than (>) 40 international units per liter (IU/L)
-
Must weigh ≥50 kilograms (kg) at time of screening and dosing
-
Acceptable sitting blood pressure (BP) per the following American Heart Association (AHA) guidelines:
-
Normal: systolic blood pressure (SBP) <120 millimeters of mercury (mmHg) and diastolic blood pressure (DBP) <80 mmHg
-
Prehypertension: SBP 120-139 or DBP 80-89
-
High Blood Pressure (Hypertension) Stage 1: SBP 140-159 mmHg or DBP 90-99
-
Have given written informed consent prior to any study-specific procedures
-
Are reliable and willing to make themselves available for the duration of the study and are willing to follow site specific study procedures
-
Have venous access sufficient to allow blood sampling
-
Have laboratory values and other safety parameters that are, in the opinion of the investigator, acceptable fo participation for the study
Exclusion Criteria:
-
Have a diagnosis of chronic kidney disease (CKD) other than DKD, (hypertensive nephrosclerosis superimposed on DKD is acceptable)
-
Have SBP >160 mmHg or DBP >100 mmHg
o Individuals with Stage 1 BP elevation (SBP 140-159 mmHg or DBP 90-99 mmHg) on some occasions during study, may be acceptable, as long as only non-protein-lowering antihypertensives are adjusted to achieve target BP goals (<140/90 mmHg)
-
Current use of (or within 2 weeks of enrollment), or projected need for a renin inhibitor or aldosterone antagonist, or a combination of Angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACEi/ARB)
-
Individuals in whom dialysis or transplantation is anticipated within 6 months of screening
-
Have a history of acute kidney injury within 3 months of screening
-
Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational drug that has not received regulatory approval for any indication and/or have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives of the administered drug (whichever is longer) prior to dosing
-
Have previously completed or withdrawn from this study or any other study investigating LY3016859
-
Have a diagnosis of Class III or IV congestive heart failure (as defined by the New York Heart Association)
-
Have an abnormality in the 12-lead Electrocardiogram (ECG) that, in the opinion of the investigator increases the risks associated with participating in the study. In addition, individuals with the following findings will be excluded:
-
Confirmed corrected QT (QTcF) interval >450 milliseconds (msec) for men and >470 msec for women
-
Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular ectopic beats
-
History of unexplained syncope
-
Family history of unexplained sudden death or sudden death due to long QT syndrome
-
T-wave configurations are not of sufficient quality for assessing QT interval, as determined by the investigator
-
Have evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies; have a history of cirrhosis or hepatitis C or are positive for hepatitis C antibody at the screening visit; are known to be hepatitis B surface antigen-positive or are positive for hepatitis B surface antigen at the screening visit
-
Are unwilling to discontinue use of Chinese herbs for at least 2 weeks prior to randomization and for the duration of their study participation
-
Are unwilling or unable to comply with the use of a data collection device to directly record data from the participant
-
Have donated blood of more than 500 milliliters (mL) within the last 60 days prior to screening
-
Have an average weekly alcohol intake that exceeds 21 units per week or are unwilling to stop alcohol intake within 48 hours of entry into study and for the duration of the study (1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
-
Individuals who, in the opinion of the investigator, show evidence of regular use of drugs of abuse
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Innovative Research of West Florida | Clearwater | Florida | United States | 33756 |
| 2 | Creighton University Medical Center | Omaha | Nebraska | United States | 68131 |
| 3 | Northeast Clinical Research Center | Bethlehem | Pennsylvania | United States | 18017 |
| 4 | Southeast Renal Research Institute | Chattanooga | Tennessee | United States | 37408 |
| 5 | TAD Clinical Research | Lufkin | Texas | United States | 75904 |
| 6 | Renal Associates, PA | San Antonio | Texas | United States | 78215 |
| 7 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sofia | Bulgaria | 1612 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLilly (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST_, Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01774981
Other Study ID Numbers:
- 14353
- I5V-MC-TGAB
- 2012-004496-40
First Posted:
Jan 24, 2013
Last Update Posted:
Sep 19, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo (Part A) | 10 mg LY3016859 (Part A) | 100 mg LY3016859 (Part A) | 750 mg LY3016859 (Part A) | Placebo (Part B) | 50 mg LY3016859 (Part B) | 250 mg LY3016859 (Part B) | 750 mg LY3016859 (Part B) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4. | Part A: 10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. | Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. | Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. | Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. |
| Period Title: Overall Study | ||||||||
| STARTED | 3 | 4 | 4 | 4 | 6 | 14 | 13 | 12 |
| Received at Least 1 Dose of Study Drug | 3 | 4 | 4 | 4 | 6 | 14 | 13 | 12 |
| COMPLETED | 3 | 4 | 4 | 4 | 5 | 13 | 13 | 11 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Placebo (Part A) | 10 mg LY3016859 (Part A) | 100 mg LY3016859 (Part A) | 750 mg LY3016859 (Part A) | Placebo (Part B) | 50 mg LY3016859 (Part B) | 250 mg LY3016859 (Part B) | 750 mg LY3016859 (Part B) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4. | Part A: 10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. | Part A:100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. | Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. | Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Total of all reporting groups |
| Overall Participants | 3 | 4 | 4 | 4 | 6 | 14 | 13 | 12 | 60 |
| Age (years) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [years] |
61
(10.0)
|
57
(7.2)
|
56
(6.1)
|
62
(11.6)
|
55
(5.0)
|
63
(8.3)
|
55
(12.7)
|
59
(9.5)
|
58.5
(9.6)
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
1
33.3%
|
1
25%
|
2
50%
|
2
50%
|
5
83.3%
|
7
50%
|
4
30.8%
|
6
50%
|
28
46.7%
|
| Male |
2
66.7%
|
3
75%
|
2
50%
|
2
50%
|
1
16.7%
|
7
50%
|
9
69.2%
|
6
50%
|
32
53.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
4
28.6%
|
0
0%
|
5
41.7%
|
10
16.7%
|
| Not Hispanic or Latino |
3
100%
|
4
100%
|
4
100%
|
4
100%
|
5
83.3%
|
10
71.4%
|
13
100%
|
7
58.3%
|
50
83.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
14.3%
|
0
0%
|
0
0%
|
2
3.3%
|
| White |
3
100%
|
4
100%
|
4
100%
|
4
100%
|
6
100%
|
12
85.7%
|
13
100%
|
12
100%
|
58
96.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||||||||
| United States |
0
0%
|
2
50%
|
0
0%
|
0
0%
|
3
50%
|
10
71.4%
|
13
100%
|
9
75%
|
37
61.7%
|
| Bulgaria |
1
33.3%
|
2
50%
|
3
75%
|
2
50%
|
3
50%
|
4
28.6%
|
0
0%
|
3
25%
|
18
30%
|
| United Kingdom |
2
66.7%
|
0
0%
|
1
25%
|
2
50%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
5
8.3%
|
Outcome Measures
| Title | Part B:Change From Baseline in Proteinuria |
|---|---|
| Description | Proteinuria is defined as the ratio of protein to creatinine. |
| Time Frame | Baseline, 16 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo (Part B) | 50 mg LY3016859 (Part B) | 250 mg LY3016859 (Part B) | 750 mg LY3016859 (Part B) |
|---|---|---|---|---|
| Arm/Group Description | Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. |
| Measure Participants | 6 | 9 | 9 | 11 |
| Mean (Standard Deviation) [grams per 12 hour (g/12 hour)] |
1.5
(2.04)
|
-0.4
(1.60)
|
0.1
(1.21)
|
0.7
(2.23)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo (Part B), 50 mg LY3016859 (Part B) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0449 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo (Part B), 250 mg LY3016859 (Part B) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0808 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo (Part B), 750 mg LY3016859 (Part B) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2219 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Part A and Part B: Number of Participants With One or More Treatment Emergent Adverse Events (AEs) or Any Serious AEs |
|---|---|
| Description | 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. |
| Time Frame | Baseline up to 32 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug. |
| Arm/Group Title | Placebo (Part A) | 10 mg LY3016859 (Part A) | 100 mg LY3016859 (Part A) | 750 mg LY3016859 (Part A) | Placebo (Part B) | 50 mg LY3016859 (Part B) | 250 mg LY3016859 (Part B) | 750 mg LY3016859 (Part B) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4. | Part A:10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. | Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. | Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. | Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. |
| Measure Participants | 3 | 4 | 4 | 4 | 6 | 14 | 13 | 12 |
| Count of Participants [Participants] |
1
33.3%
|
3
75%
|
4
100%
|
2
50%
|
6
100%
|
13
92.9%
|
13
100%
|
11
91.7%
|
| Title | Part B: Change From Baseline in Proteinuria Over Time |
|---|---|
| Description | Proteinuria is defined as the ratio of protein to creatinine. |
| Time Frame | Baseline, 19 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo (Part B) | 50 mg LY3016859 (Part B) | 250 mg LY3016859 (Part B) | 750 mg LY3016859 (Part B) |
|---|---|---|---|---|
| Arm/Group Description | Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. |
| Measure Participants | 5 | 11 | 12 | 11 |
| Mean (Standard Deviation) [mg/dl of protein/ by mg/dl of creatinine] |
19.3
(154.66)
|
-17.3
(81.95)
|
-2.4
(88.01)
|
48.6
(130.13)
|
| Title | Part B: Change From Baseline in Albuminuria Over Time |
|---|---|
| Description | Albuminuria is defined as the ratio of albumin to creatinine. |
| Time Frame | Baseline, 19 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo (Part B) | 50 mg LY3016859 (Part B) | 250 mg LY3016859 (Part B) | 750 mg LY3016859 (Part B) |
|---|---|---|---|---|
| Arm/Group Description | Part B:Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. |
| Measure Participants | 5 | 11 | 12 | 11 |
| Mean (Standard Deviation) [mg/dl of albumin/ by mg/dl of creatinine] |
8.6
(100.57)
|
-15.6
(64.27)
|
-8.1
(50.19)
|
36.7
(93.49)
|
Adverse Events
| Time Frame | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||
| Arm/Group Title | Placebo (Part A) | 10 mg LY3016859 (Part A) | 100 mg LY3016859 (Part A) | 750 mg LY3016859 (Part A) | Placebo (Part B) | 50 mg LY3016859 (Part B) | 250 mg LY3016859 (Part B) | 750 mg LY3016859 (Part B) | ||||||||
| Arm/Group Description | Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4. | Part A:10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. | Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. | Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. | Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. | ||||||||
All Cause Mortality |
||||||||||||||||
| Placebo (Part A) | 10 mg LY3016859 (Part A) | 100 mg LY3016859 (Part A) | 750 mg LY3016859 (Part A) | Placebo (Part B) | 50 mg LY3016859 (Part B) | 250 mg LY3016859 (Part B) | 750 mg LY3016859 (Part B) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/14 (0%) | 0/13 (0%) | 0/12 (0%) | ||||||||
Serious Adverse Events |
||||||||||||||||
| Placebo (Part A) | 10 mg LY3016859 (Part A) | 100 mg LY3016859 (Part A) | 750 mg LY3016859 (Part A) | Placebo (Part B) | 50 mg LY3016859 (Part B) | 250 mg LY3016859 (Part B) | 750 mg LY3016859 (Part B) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/6 (16.7%) | 3/14 (21.4%) | 6/13 (46.2%) | 2/12 (16.7%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| Anginal pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Atrial fibrillation aggravated | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Atrial fibrillation with rapid ventricular response | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Congestive heart failure | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||
| Gastrointestinal bleed | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Phytobezoar | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| General disorders | ||||||||||||||||
| Sudden death | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||||||
| Acalculous cholecystitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Infections and infestations | ||||||||||||||||
| Chronic lower extremity cellulitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Clostridium difficile colitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Peritonitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||
| Lacunar infarction | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Transient ischemic attack | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Dyspnea | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Surgical and medical procedures | ||||||||||||||||
| Femoropopliteal artery bypass | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| Placebo (Part A) | 10 mg LY3016859 (Part A) | 100 mg LY3016859 (Part A) | 750 mg LY3016859 (Part A) | Placebo (Part B) | 50 mg LY3016859 (Part B) | 250 mg LY3016859 (Part B) | 750 mg LY3016859 (Part B) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/3 (33.3%) | 3/4 (75%) | 4/4 (100%) | 2/4 (50%) | 6/6 (100%) | 13/14 (92.9%) | 13/13 (100%) | 11/12 (91.7%) | ||||||||
| Blood and lymphatic system disorders | ||||||||||||||||
| Anemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Anemia aggravated | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Leukocytosis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Cardiac disorders | ||||||||||||||||
| Bradycardia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 1/12 (8.3%) | 1 |
| Heart pounding | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Tachycardia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Eye disorders | ||||||||||||||||
| Cloudy vision | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Glaucoma | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Right cataract | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Tearing decreased | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Visual acuity reduced | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||
| Abdominal cramps | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Abdominal fullness | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Colitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Diarrhea | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 1/13 (7.7%) | 1 | 2/12 (16.7%) | 2 |
| Distress gastrointestinal | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Dry heaves | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Dry mouth | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Heartburn | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Nausea | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/14 (7.1%) | 1 | 2/13 (15.4%) | 4 | 1/12 (8.3%) | 1 |
| Toothache | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Vomiting | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/14 (7.1%) | 1 | 1/13 (7.7%) | 2 | 0/12 (0%) | 0 |
| General disorders | ||||||||||||||||
| Application site pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Chest pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Coldness general | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Edema aggravated | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 3/14 (21.4%) | 3 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Edema generalized | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Fatigue aggravated | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 2/12 (16.7%) | 2 |
| Fever | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| General body pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Swelling of legs | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Systemic inflammatory response syndrome | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Infusion Site Erythema | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||||||
| Portal vein phlebitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Immune system disorders | ||||||||||||||||
| Hay fever | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Infections and infestations | ||||||||||||||||
| Alpha hemolytic streptococcal infection | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Axillary abscess | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Bacterial infection due to unspecified staphylococcus | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Bronchitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 1/12 (8.3%) | 1 |
| Cellulitis of hand | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Cellulitis of leg | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Cold | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Common cold | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Conjunctivitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Dental abscess | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Flu | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Folliculitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Head cold | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Influenza | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Kidney infection | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Leg infection | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Sinusitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Tooth infection | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Upper respiratory infection | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 2/14 (14.3%) | 2 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Urinary tract infection | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 2/14 (14.3%) | 2 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Urinary tract yeast infection | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Viral infection | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/14 (7.1%) | 2 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Viral labyrinthitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Viral syndrome | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||
| Abrasions | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Ankle sprain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Bruising | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Excoriation | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| First degree burns | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Flea bite | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Hematoma traumatic | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Lower limb wound | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Skin laceration | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Spider bite | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Sprained ankle | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Wound | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 2/14 (14.3%) | 2 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Investigations | ||||||||||||||||
| Bicarbonate decreased serum | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Blood creatinine increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Blood glucose increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 2 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Blood pressure increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Cholesterol levels raised | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Ecg abnormal | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Fasting blood glucose abnormal | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Increased intraocular pressure | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Platelets decreased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Potassium abnormal | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Potassium increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Renal function test abnormal | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Thyroid function test abnormal | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 2 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Uric acid level increased | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Weight gain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||
| Appetite lost | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Dehydration | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Fasting hyperglycemia | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Gout aggravated | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Gout flare | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 2/12 (16.7%) | 2 |
| Hyperkalemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Hypoglycemia | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/4 (25%) | 2 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Hypoglycemia aggravated | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Hypokalemia | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Metabolic acidosis worsened | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Volume depletion | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Volume overload | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 2/14 (14.3%) | 2 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Back pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Chest wall pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Flank pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Foot pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Low back pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Muscle cramps | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 2/14 (14.3%) | 2 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Pain in thumb | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Shoulder pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||
| Skin papilloma | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Squamous cell carcinoma | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Thyroid nodule | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||
| Dizziness | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Headache | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 1/4 (25%) | 2 | 0/4 (0%) | 0 | 2/6 (33.3%) | 2 | 1/14 (7.1%) | 1 | 2/13 (15.4%) | 2 | 1/12 (8.3%) | 1 |
| Headache aggravated | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Lightheadedness | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Numbness | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Presyncope | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Sciatica aggravated | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Crawling Sensation | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Numbness in Feet | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Body Numbness | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||||
| Depression worsened | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Difficulty sleeping | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||||
| Acute kidney injury | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Chronic kidney disease | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 2/6 (33.3%) | 2 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Diuresis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Kidney function abnormal | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Urinary retention | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||||||
| Nipple pain | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Allergic rhinitis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Cough | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Cough nonproductive | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Dyspnea | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Epistaxis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Laryngeal cyst | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Nosebleed | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Pleural effusion | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Rhinorrhea | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Sore throat | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Supine dyspnea | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Runny Nose | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Acne | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 2/13 (15.4%) | 2 | 0/12 (0%) | 0 |
| Blister | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Diaphoresis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Ecchymosis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Erythema | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Generalized itching | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Itching | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 2/12 (16.7%) | 2 |
| Localised rash | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 2 |
| Localized erythema | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Papular rash | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Pruritis | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Rosacea | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Skin inflammation | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Skin irritation | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Skin peeling | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Surgical and medical procedures | ||||||||||||||||
| Mohs micrographic surgery | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Squamous cell carcinoma excision | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 1/13 (7.7%) | 2 | 0/12 (0%) | 0 |
| Vascular disorders | ||||||||||||||||
| Blood pressure high | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Flushing of face | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/14 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Hematoma | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Hypertension exacerbated | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/14 (7.1%) | 1 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
| Hypertension worsened | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/14 (7.1%) | 1 | 2/13 (15.4%) | 2 | 1/12 (8.3%) | 1 |
| Orthostatic hypotension | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 2/14 (14.3%) | 2 | 0/13 (0%) | 0 | 0/12 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01774981
Other Study ID Numbers:
- 14353
- I5V-MC-TGAB
- 2012-004496-40
First Posted:
Jan 24, 2013
Last Update Posted:
Sep 19, 2019
Last Verified:
Sep 1, 2019