Trial Outcomes & Findings for A Single Dose Study of LY2189265 in Subjects With Varying Degrees of Hepatic (Liver) Impairment (NCT NCT01253304)
NCT ID: NCT01253304
Last Updated: 2014-10-07
Results Overview
This measure was calculated using non-compartmental analysis techniques.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Predose to 336 hours postdose
Results posted on
2014-10-07
Participant Flow
Participant milestones
| Measure |
Normal Hepatic Function
LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
|
Mild Hepatic Impairment
LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
6
|
6
|
3
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
11
|
6
|
6
|
3
|
|
Overall Study
COMPLETED
|
11
|
6
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Normal Hepatic Function
LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
|
Mild Hepatic Impairment
LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Single Dose Study of LY2189265 in Subjects With Varying Degrees of Hepatic (Liver) Impairment
Baseline characteristics by cohort
| Measure |
Normal Hepatic Function
n=11 Participants
LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
|
Mild Hepatic Impairment
n=6 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
n=6 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
n=3 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
54.3 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
64.3 years
STANDARD_DEVIATION 6.5 • n=4 Participants
|
57.6 years
STANDARD_DEVIATION 7.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 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
|
|
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
|
|
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
|
|
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
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
3 participants
n=4 Participants
|
26 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
3 participants
n=4 Participants
|
26 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Predose to 336 hours postdosePopulation: Participants who received at least one dose of study drug (LY2189265) with evaluable concentration data.
This measure was calculated using non-compartmental analysis techniques.
Outcome measures
| Measure |
Normal Hepatic Function
n=11 Participants
LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
|
Mild Hepatic Impairment
n=6 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
n=6 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
n=3 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
|
|---|---|---|---|---|
|
Pharmacokinetics: Maximum Observed Concentration (Cmax)
|
84.5 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 29
|
63.0 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 30
|
58.1 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
61.3 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 18
|
PRIMARY outcome
Timeframe: Predose to 336 hours postdosePopulation: Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.
This measure was calculated using non-compartmental analysis techniques.
Outcome measures
| Measure |
Normal Hepatic Function
n=11 Participants
LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
|
Mild Hepatic Impairment
n=6 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
n=6 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
n=3 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
|
|---|---|---|---|---|
|
Pharmacokinetics: Time of Maximum Concentration (Tmax)
|
48.00 hours
Interval 24.02 to 72.02
|
48.01 hours
Interval 47.95 to 72.02
|
59.96 hours
Interval 47.1 to 95.97
|
71.93 hours
Interval 71.9 to 71.98
|
PRIMARY outcome
Timeframe: Predose to 336 hours postdosePopulation: Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.
This measure was calculated using non-compartmental analysis techniques.
Outcome measures
| Measure |
Normal Hepatic Function
n=11 Participants
LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
|
Mild Hepatic Impairment
n=6 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
n=6 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
n=3 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
|
|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-tlast])
|
10200 nanograms times hour/milliliter(ng*hr/mL
Geometric Coefficient of Variation 26
|
7670 nanograms times hour/milliliter(ng*hr/mL
Geometric Coefficient of Variation 27
|
7220 nanograms times hour/milliliter(ng*hr/mL
Geometric Coefficient of Variation 19
|
7660 nanograms times hour/milliliter(ng*hr/mL
Geometric Coefficient of Variation 13
|
PRIMARY outcome
Timeframe: Predose to 336 hours postdosePopulation: Participants who received at least one dose of study drug (LY2189265) with evaluable concentration data.
This measure was calculated using non-compartmental analysis techniques.
Outcome measures
| Measure |
Normal Hepatic Function
n=11 Participants
LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
|
Mild Hepatic Impairment
n=6 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
n=5 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
n=3 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
|
|---|---|---|---|---|
|
Pharmacokinetics: AUC From Time Zero to Infinity (AUC[0-infinity])
|
16300 nanograms times hr/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 24
|
12200 nanograms times hr/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
11200 nanograms times hr/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 14
|
12500 nanograms times hr/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 5
|
PRIMARY outcome
Timeframe: Predose to 336 hours postdosePopulation: Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.
The half life associated with the terminal rate constant is summarized. This measure was calculated using non-compartmental analysis techniques.
Outcome measures
| Measure |
Normal Hepatic Function
n=11 Participants
LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
|
Mild Hepatic Impairment
n=6 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
n=5 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
n=3 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
|
|---|---|---|---|---|
|
Pharmacokinetics: Apparent Terminal Elimination Half-life (t1/2)
|
104 hours
Interval 88.6 to 116.0
|
101 hours
Interval 86.2 to 116.0
|
88.2 hours
Interval 75.1 to 104.0
|
99.2 hours
Interval 76.4 to 121.0
|
PRIMARY outcome
Timeframe: Predose to 336 hours postdosePopulation: Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.
The apparent total body clearance of drug calculated after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.
Outcome measures
| Measure |
Normal Hepatic Function
n=11 Participants
LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
|
Mild Hepatic Impairment
n=6 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
n=5 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
n=3 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
|
|---|---|---|---|---|
|
Pharmacokinetics: Apparent Total Plasma Clearance (CL/F)
|
0.0920 liters/hour (L/h)
Geometric Coefficient of Variation 24
|
0.123 liters/hour (L/h)
Geometric Coefficient of Variation 26
|
0.135 liters/hour (L/h)
Geometric Coefficient of Variation 14
|
0.120 liters/hour (L/h)
Geometric Coefficient of Variation 5
|
PRIMARY outcome
Timeframe: Predose to 336 hours postdosePopulation: Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.
The apparent volume of distribution during the terminal phase after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.
Outcome measures
| Measure |
Normal Hepatic Function
n=11 Participants
LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
|
Mild Hepatic Impairment
n=6 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
n=5 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
n=3 Participants
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
|
|---|---|---|---|---|
|
Pharmacokinetics: Apparent Volume of Distribution (Vz/F)
|
13.8 liters (L)
Geometric Coefficient of Variation 27
|
17.9 liters (L)
Geometric Coefficient of Variation 27
|
17.1 liters (L)
Geometric Coefficient of Variation 20
|
17.1 liters (L)
Geometric Coefficient of Variation 24
|
Adverse Events
Normal Hepatic Function
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Mild Hepatic Impairment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Moderate Hepatic Impairment
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Severe Hepatic Impairment
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Normal Hepatic Function
n=11 participants at risk
LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
|
Mild Hepatic Impairment
n=6 participants at risk
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
n=6 participants at risk
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
n=3 participants at risk
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/11
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/11
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/11
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/11
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/11
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
Other adverse events
| Measure |
Normal Hepatic Function
n=11 participants at risk
LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
|
Mild Hepatic Impairment
n=6 participants at risk
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
|
Moderate Hepatic Impairment
n=6 participants at risk
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
|
Severe Hepatic Impairment
n=3 participants at risk
LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/11
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/11
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
18.2%
2/11 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
1/11 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Constipation
|
18.2%
2/11 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Dyspepsia
|
18.2%
2/11 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/11
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Eructation
|
27.3%
3/11 • Number of events 3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/11
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/11
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
27.3%
3/11 • Number of events 3
|
33.3%
2/6 • Number of events 6
|
0.00%
0/6
|
0.00%
0/3
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/11
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/11
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
2/11 • Number of events 3
|
16.7%
1/6 • Number of events 5
|
0.00%
0/6
|
0.00%
0/3
|
|
General disorders
Fatigue
|
9.1%
1/11 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/11
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/11
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
27.3%
3/11 • Number of events 3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/11
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Rhinitis
|
0.00%
0/11
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
|
Investigations
Alanine aminotransferase increased
|
18.2%
2/11 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
1/11 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
|
Investigations
Lipase increased
|
0.00%
0/11
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
72.7%
8/11 • Number of events 8
|
66.7%
4/6 • Number of events 4
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/11
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.1%
1/11 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebral hygroma
|
0.00%
0/11
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Number of events 3
|
16.7%
1/6 • Number of events 3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/11
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
9.1%
1/11 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
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