Trial Outcomes & Findings for A Study of Evacetrapib in Participants With Abnormal Cholesterol (NCT NCT02168803)
NCT ID: NCT02168803
Last Updated: 2018-10-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
101 participants
Primary outcome timeframe
Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
Results posted on
2018-10-03
Participant Flow
Participants were enrolled into 3 parallel cohorts. Each participant received a single dose, after which PK was evaluated for 7 days, and then continued receiving once daily doses for 12, 24, or 52 weeks. After the last once-daily dose, PK was again evaluated in each participant until the concentration of evacetrapib was too low to be measurable.
Participant milestones
| Measure |
Evacetrapib: Multiple Dose 12 Weeks
130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12 consecutive weeks.
|
Evacetrapib: Multiple Dose 24 Weeks
130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 24 consecutive weeks.
|
Evacetrapib: Multiple Dose 52 Weeks
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
32
|
39
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
30
|
32
|
39
|
|
Overall Study
COMPLETED
|
28
|
29
|
33
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
6
|
Reasons for withdrawal
| Measure |
Evacetrapib: Multiple Dose 12 Weeks
130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12 consecutive weeks.
|
Evacetrapib: Multiple Dose 24 Weeks
130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 24 consecutive weeks.
|
Evacetrapib: Multiple Dose 52 Weeks
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Evacetrapib in Participants With Abnormal Cholesterol
Baseline characteristics by cohort
| Measure |
Evacetrapib: Multiple Dose 12 Weeks
n=30 Participants
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks
|
Evacetrapib: Multiple Dose 24 Weeks
n=32 Participants
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks
|
Evacetrapib: Multiple Dose 52 Weeks
n=39 Participants
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 14.9 • n=7 Participants
|
56.4 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
88 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
71 Participants
n=4 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
|
|
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
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post DosePopulation: All enrolled participants who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Evacetrapib: Single Dose, All Participants
n=101 Participants
A single 130 mg oral dose of evacetrapib was administered on Day 1 to all participants. 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12, 24, and 52 consecutive weeks.
|
Evacetrapib: Multiple Dose 12 Weeks
n=27 Participants
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks
|
Evacetrapib: Multiple Dose 24 Weeks
n=30 Participants
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.
|
Evacetrapib: Multiple Dose 52 Weeks
n=29 Participants
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast])
|
14200 nanogram∙hour/mililliter (ng∙h/mL)
Geometric Coefficient of Variation 28
|
37400 nanogram∙hour/mililliter (ng∙h/mL)
Geometric Coefficient of Variation 43
|
36900 nanogram∙hour/mililliter (ng∙h/mL)
Geometric Coefficient of Variation 39
|
44400 nanogram∙hour/mililliter (ng∙h/mL)
Geometric Coefficient of Variation 32
|
PRIMARY outcome
Timeframe: Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post DosePopulation: All enrolled participants who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Evacetrapib: Single Dose, All Participants
n=101 Participants
A single 130 mg oral dose of evacetrapib was administered on Day 1 to all participants. 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12, 24, and 52 consecutive weeks.
|
Evacetrapib: Multiple Dose 12 Weeks
n=27 Participants
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks
|
Evacetrapib: Multiple Dose 24 Weeks
n=30 Participants
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.
|
Evacetrapib: Multiple Dose 52 Weeks
n=29 Participants
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
|
|---|---|---|---|---|
|
PK Parameters of Evacetrapib: Maximum Concentration (Cmax)
|
1020 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
1690 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 41
|
1770 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
1850 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
PRIMARY outcome
Timeframe: Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post DosePopulation: A single terminal half-life estimate was calculated from population PK estimates for apparent clearance and apparent volume of distribution across all participants, based on all available single dose data and multiple dose data.
Outcome measures
| Measure |
Evacetrapib: Single Dose, All Participants
n=101 Participants
A single 130 mg oral dose of evacetrapib was administered on Day 1 to all participants. 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12, 24, and 52 consecutive weeks.
|
Evacetrapib: Multiple Dose 12 Weeks
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks
|
Evacetrapib: Multiple Dose 24 Weeks
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.
|
Evacetrapib: Multiple Dose 52 Weeks
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
|
|---|---|---|---|---|
|
PK Parameters of Evacetrapib: Terminal Half-life
|
52.5 Days
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -1, Day 8Population: All enrolled participants in the single dose phase and had evaluable PD data.
Outcome measures
| Measure |
Evacetrapib: Single Dose, All Participants
n=30 Participants
A single 130 mg oral dose of evacetrapib was administered on Day 1 to all participants. 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12, 24, and 52 consecutive weeks.
|
Evacetrapib: Multiple Dose 12 Weeks
n=32 Participants
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks
|
Evacetrapib: Multiple Dose 24 Weeks
n=39 Participants
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.
|
Evacetrapib: Multiple Dose 52 Weeks
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
|
|---|---|---|---|---|
|
PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level
Single-Dose Phase Day -1
|
1.538 millimole/Liter (mmol/L)
Standard Deviation 0.416
|
1.562 millimole/Liter (mmol/L)
Standard Deviation 0.395
|
1.670 millimole/Liter (mmol/L)
Standard Deviation 0.548
|
—
|
|
PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level
Single-dose Phase Day 8
|
1.724 millimole/Liter (mmol/L)
Standard Deviation 0.493
|
1.777 millimole/Liter (mmol/L)
Standard Deviation 0.443
|
1.772 millimole/Liter (mmol/L)
Standard Deviation 0.552
|
—
|
SECONDARY outcome
Timeframe: Day -1, Day 8Population: All enrolled participants who received at least 1 dose of study drug and had evaluable PD data.
Outcome measures
| Measure |
Evacetrapib: Single Dose, All Participants
n=30 Participants
A single 130 mg oral dose of evacetrapib was administered on Day 1 to all participants. 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12, 24, and 52 consecutive weeks.
|
Evacetrapib: Multiple Dose 12 Weeks
n=32 Participants
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks
|
Evacetrapib: Multiple Dose 24 Weeks
n=39 Participants
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.
|
Evacetrapib: Multiple Dose 52 Weeks
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
|
|---|---|---|---|---|
|
PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level
Single-Dose Phase Day -1
|
3.711 mmol/L
Standard Deviation 0.958
|
3.359 mmol/L
Standard Deviation 0.835
|
3.662 mmol/L
Standard Deviation 1.039
|
—
|
|
PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level
Single-Dose Phase Day 8
|
3.173 mmol/L
Standard Deviation 0.872
|
3.152 mmol/L
Standard Deviation 0.928
|
3.293 mmol/L
Standard Deviation 1.058
|
—
|
SECONDARY outcome
Timeframe: Day -1, Day 8Population: All enrolled participants who received at least 1 dose of study drug and had evaluable PD data.
Outcome measures
| Measure |
Evacetrapib: Single Dose, All Participants
n=30 Participants
A single 130 mg oral dose of evacetrapib was administered on Day 1 to all participants. 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12, 24, and 52 consecutive weeks.
|
Evacetrapib: Multiple Dose 12 Weeks
n=32 Participants
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks
|
Evacetrapib: Multiple Dose 24 Weeks
n=39 Participants
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.
|
Evacetrapib: Multiple Dose 52 Weeks
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
|
|---|---|---|---|---|
|
PD Parameters of Evacetrapib: Total Cholesterol Level
Single-Dose Phase Day 8
|
5.577 mmol
Standard Deviation 1.224
|
5.531 mmol
Standard Deviation 0.931
|
5.715 mmol
Standard Deviation 1.179
|
—
|
|
PD Parameters of Evacetrapib: Total Cholesterol Level
Single-Dose Phase Day -1
|
5.922 mmol
Standard Deviation 1.244
|
5.523 mmol
Standard Deviation 0.736
|
6.015 mmol
Standard Deviation 1.099
|
—
|
SECONDARY outcome
Timeframe: Day -1, Day 8Population: All enrolled participants who received at least 1 dose of study drug and had evaluable PD data.
Outcome measures
| Measure |
Evacetrapib: Single Dose, All Participants
n=30 Participants
A single 130 mg oral dose of evacetrapib was administered on Day 1 to all participants. 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12, 24, and 52 consecutive weeks.
|
Evacetrapib: Multiple Dose 12 Weeks
n=32 Participants
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks
|
Evacetrapib: Multiple Dose 24 Weeks
n=39 Participants
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.
|
Evacetrapib: Multiple Dose 52 Weeks
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
|
|---|---|---|---|---|
|
PD Parameters of Evacetrapib: Triglyceride Level
Single-Dose Phase Day -1
|
1.474 mmol
Standard Deviation 0.849
|
1.311 mmol
Standard Deviation 0.815
|
1.485 mmol
Standard Deviation 0.631
|
—
|
|
PD Parameters of Evacetrapib: Triglyceride Level
Single-Dose Phase Day 8
|
1.482 mmol
Standard Deviation 1.016
|
1.309 mmol
Standard Deviation 0.871
|
1.419 mmol
Standard Deviation 0.681
|
—
|
Adverse Events
Evacetrapib: Single Dose, All Participants
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Evacetrapib: Multiple Dose 12 Weeks
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Evacetrapib: Multiple Dose 24 Weeks
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Evacetrapib: Multiple Dose 52 Weeks
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Evacetrapib: Single Dose, All Participants
n=101 participants at risk
A single 130 mg oral dose of evacetrapib was administered on Day 1 to all participants. 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12, 24, and 52 consecutive weeks.
|
Evacetrapib: Multiple Dose 12 Weeks
n=30 participants at risk
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks.
|
Evacetrapib: Multiple Dose 24 Weeks
n=32 participants at risk
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.
|
Evacetrapib: Multiple Dose 52 Weeks
n=39 participants at risk
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/101
|
0.00%
0/30
|
0.00%
0/32
|
2.6%
1/39 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/101
|
0.00%
0/30
|
0.00%
0/32
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Sudden death
|
0.00%
0/101
|
0.00%
0/30
|
0.00%
0/32
|
2.6%
1/39 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/101
|
0.00%
0/30
|
0.00%
0/32
|
2.6%
1/39 • Number of events 1
|
|
Infections and infestations
Mycetoma mycotic
|
0.00%
0/101
|
0.00%
0/30
|
0.00%
0/32
|
2.6%
1/39 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/101
|
0.00%
0/30
|
0.00%
0/32
|
2.6%
1/39 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/101
|
0.00%
0/30
|
0.00%
0/32
|
2.6%
1/39 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/101
|
0.00%
0/30
|
0.00%
0/32
|
2.6%
1/39 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/101
|
0.00%
0/30
|
0.00%
0/32
|
2.6%
1/39 • Number of events 1
|
Other adverse events
| Measure |
Evacetrapib: Single Dose, All Participants
n=101 participants at risk
A single 130 mg oral dose of evacetrapib was administered on Day 1 to all participants. 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12, 24, and 52 consecutive weeks.
|
Evacetrapib: Multiple Dose 12 Weeks
n=30 participants at risk
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks.
|
Evacetrapib: Multiple Dose 24 Weeks
n=32 participants at risk
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.
|
Evacetrapib: Multiple Dose 52 Weeks
n=39 participants at risk
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.99%
1/101 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
9.4%
3/32 • Number of events 4
|
5.1%
2/39 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
2/101 • Number of events 3
|
6.7%
2/30 • Number of events 2
|
3.1%
1/32 • Number of events 1
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.99%
1/101 • Number of events 1
|
10.0%
3/30 • Number of events 3
|
3.1%
1/32 • Number of events 1
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/101
|
6.7%
2/30 • Number of events 2
|
3.1%
1/32 • Number of events 1
|
0.00%
0/39
|
|
General disorders
Fatigue
|
0.00%
0/101
|
0.00%
0/30
|
6.2%
2/32 • Number of events 2
|
0.00%
0/39
|
|
General disorders
Pyrexia
|
0.00%
0/101
|
6.7%
2/30 • Number of events 2
|
0.00%
0/32
|
0.00%
0/39
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/101
|
0.00%
0/30
|
6.2%
2/32 • Number of events 2
|
0.00%
0/39
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/101
|
3.3%
1/30 • Number of events 1
|
12.5%
4/32 • Number of events 5
|
12.8%
5/39 • Number of events 7
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/101
|
0.00%
0/30
|
6.2%
2/32 • Number of events 2
|
5.1%
2/39 • Number of events 3
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/101
|
3.3%
1/30 • Number of events 1
|
3.1%
1/32 • Number of events 2
|
5.1%
2/39 • Number of events 3
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/101
|
0.00%
0/30
|
0.00%
0/32
|
7.7%
3/39 • Number of events 3
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/101
|
6.7%
2/30 • Number of events 4
|
0.00%
0/32
|
2.6%
1/39 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/101
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
7.7%
3/39 • Number of events 4
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/101
|
0.00%
0/30
|
6.2%
2/32 • Number of events 2
|
2.6%
1/39 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/101
|
0.00%
0/30
|
0.00%
0/32
|
5.1%
2/39 • Number of events 2
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/101
|
0.00%
0/30
|
0.00%
0/32
|
5.1%
2/39 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/101
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
5.1%
2/39 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/101
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
5.1%
2/39 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
3/101 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
10.3%
4/39 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/101
|
0.00%
0/30
|
0.00%
0/32
|
7.7%
3/39 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.99%
1/101 • Number of events 1
|
0.00%
0/30
|
6.2%
2/32 • Number of events 2
|
0.00%
0/39
|
|
Nervous system disorders
Dizziness
|
0.00%
0/101
|
0.00%
0/30
|
0.00%
0/32
|
5.1%
2/39 • Number of events 3
|
|
Nervous system disorders
Headache
|
6.9%
7/101 • Number of events 8
|
13.3%
4/30 • Number of events 6
|
9.4%
3/32 • Number of events 3
|
7.7%
3/39 • Number of events 3
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/101
|
0.00%
0/30
|
0.00%
0/32
|
5.1%
2/39 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/101
|
10.0%
3/30 • Number of events 3
|
9.4%
3/32 • Number of events 3
|
0.00%
0/39
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/101
|
0.00%
0/30
|
6.2%
2/32 • Number of events 2
|
0.00%
0/39
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/101
|
0.00%
0/30
|
6.2%
2/32 • Number of events 2
|
10.3%
4/39 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/101
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
7.7%
3/39 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/101
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
5.1%
2/39 • Number of events 2
|
|
Vascular disorders
Hypertension
|
0.00%
0/101
|
0.00%
0/30
|
0.00%
0/32
|
5.1%
2/39 • Number of events 2
|
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