Trial Outcomes & Findings for The Effects of LY2409021 on the Liver (NCT NCT01588366)
NCT ID: NCT01588366
Last Updated: 2019-03-07
Results Overview
Measured by magnetic resonance (MR) scanning.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Baseline, Day 28 (Pre-meal)
Results posted on
2019-03-07
Participant Flow
Study started in April, 2012 with Part A. Part B was added per protocol amendment in September, 2012.
Participant milestones
| Measure |
Placebo - Healthy (Part A)
Placebo administered orally, once daily (QD) for 28 days to healthy participants.
|
60 mg LY2409021 - Healthy (Part A)
60 milligrams (mg) LY2409021 administered orally, QD for 28 days to healthy participants.
|
Placebo - T2DM (Part A)
Placebo administered orally, QD for 28 days to participants with type 2 diabetes mellitus (T2DM).
|
60 mg LY2409021 - T2DM (Part A)
60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
Placebo - T2DM (Part B)
Placebo administered orally, QD for 28 days to participants with T2DM.
|
15 mg LY2409021 - T2DM (Part B)
15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
7
|
2
|
7
|
3
|
9
|
|
Overall Study
Received at Least One Dose of Study Drug
|
2
|
7
|
2
|
7
|
3
|
9
|
|
Overall Study
COMPLETED
|
2
|
6
|
2
|
6
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo - Healthy (Part A)
Placebo administered orally, once daily (QD) for 28 days to healthy participants.
|
60 mg LY2409021 - Healthy (Part A)
60 milligrams (mg) LY2409021 administered orally, QD for 28 days to healthy participants.
|
Placebo - T2DM (Part A)
Placebo administered orally, QD for 28 days to participants with type 2 diabetes mellitus (T2DM).
|
60 mg LY2409021 - T2DM (Part A)
60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
Placebo - T2DM (Part B)
Placebo administered orally, QD for 28 days to participants with T2DM.
|
15 mg LY2409021 - T2DM (Part B)
15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
1
|
0
|
2
|
Baseline Characteristics
The Effects of LY2409021 on the Liver
Baseline characteristics by cohort
| Measure |
Placebo - Healthy (Part A)
n=2 Participants
Placebo administered orally, QD for 28 days to healthy participants.
|
60 mg LY2409021 - Healthy (Part A)
n=7 Participants
60 mg LY2409021 administered orally, QD for 28 days to healthy participants.
|
Placebo - T2DM (Parts A and B)
n=5 Participants
Placebo administered orally, QD for 28 days to participants with T2DM.
|
15 mg LY2409021 - T2DM (Part B)
n=9 Participants
15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
60 mg LY2409021 - T2DM (Part A)
n=7 Participants
60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
Healthy Participants
|
49.5 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=4 Participants
|
NA years
STANDARD_DEVIATION NA • n=21 Participants
|
41.6 years
STANDARD_DEVIATION 13.2 • n=8 Participants
|
|
Age, Continuous
T2DM subjects
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 7.9 • n=4 Participants
|
51.4 years
STANDARD_DEVIATION 10.0 • n=21 Participants
|
55.3 years
STANDARD_DEVIATION 8.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
Singapore
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 28 (Pre-meal)Population: All participants who had evaluable MR scans at Baseline and on Day 28.
Measured by magnetic resonance (MR) scanning.
Outcome measures
| Measure |
Placebo - Healthy (Part A)
n=2 Participants
Placebo administered orally, QD for 28 days to healthy participants.
|
60 mg LY2409021 - Healthy (Part A)
n=6 Participants
60 mg LY2409021 administered orally, QD for 28 days to healthy participants.
|
Placebo - T2DM (Parts A and B)
n=5 Participants
Placebo administered orally, QD for 28 days to participants with T2DM.
|
15 mg LY2409021 - T2DM (Part B)
n=7 Participants
15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
60 mg LY2409021 - T2DM (Part A)
n=6 Participants
60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
|---|---|---|---|---|---|
|
Change From Baseline to Day 28 in Liver Fat Average Percent (%)
|
-0.47 percentage of liver fat average
For n=2, confidence Intervals were not calculated due to few participants.
|
5.55 percentage of liver fat average
Interval 0.346 to 10.7
|
-1.49 percentage of liver fat average
Interval -5.0 to 2.03
|
4.45 percentage of liver fat average
Interval 1.66 to 7.24
|
5.84 percentage of liver fat average
Interval 3.17 to 8.51
|
PRIMARY outcome
Timeframe: Baseline, Day 28 (Pre-meal)Population: All participants in Part A who received 60 mg LY2409021 and had evaluable MR scans at Baseline and on Day 28.
Measured by MR scanning.
Outcome measures
| Measure |
Placebo - Healthy (Part A)
n=6 Participants
Placebo administered orally, QD for 28 days to healthy participants.
|
60 mg LY2409021 - Healthy (Part A)
n=5 Participants
60 mg LY2409021 administered orally, QD for 28 days to healthy participants.
|
Placebo - T2DM (Parts A and B)
Placebo administered orally, QD for 28 days to participants with T2DM.
|
15 mg LY2409021 - T2DM (Part B)
15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
60 mg LY2409021 - T2DM (Part A)
60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
|---|---|---|---|---|---|
|
Change From Baseline to Day 28 in Hepatic Glycogen Content
|
12.8 millimoles per liter (mmol/L)
Interval -48.1 to 73.8
|
42.1 millimoles per liter (mmol/L)
Interval -8.18 to 92.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 28Population: All participants who had evaluable transaminase levels at Baseline and on Day 28.
Outcome measures
| Measure |
Placebo - Healthy (Part A)
n=2 Participants
Placebo administered orally, QD for 28 days to healthy participants.
|
60 mg LY2409021 - Healthy (Part A)
n=6 Participants
60 mg LY2409021 administered orally, QD for 28 days to healthy participants.
|
Placebo - T2DM (Parts A and B)
n=5 Participants
Placebo administered orally, QD for 28 days to participants with T2DM.
|
15 mg LY2409021 - T2DM (Part B)
n=7 Participants
15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
60 mg LY2409021 - T2DM (Part A)
n=6 Participants
60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
|---|---|---|---|---|---|
|
Change From Baseline to Day 28 in Transaminase Levels
Alanine aminotransferase (ALT)
|
-0.5 units per liter (U/L)
Standard Deviation 0.7
|
47.7 units per liter (U/L)
Standard Deviation 51.6
|
-3.5 units per liter (U/L)
Standard Deviation 4.3
|
15.7 units per liter (U/L)
Standard Deviation 15.1
|
13.3 units per liter (U/L)
Standard Deviation 5.8
|
|
Change From Baseline to Day 28 in Transaminase Levels
Aspartate aminotransferase (AST)
|
0.3 units per liter (U/L)
Standard Deviation 3.2
|
22.2 units per liter (U/L)
Standard Deviation 22.8
|
-0.2 units per liter (U/L)
Standard Deviation 3.7
|
9.9 units per liter (U/L)
Standard Deviation 9.5
|
7.7 units per liter (U/L)
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Baseline, Day 29Population: Zero participants were analyzed for this outcome measure because glucose response data was not collected or included in the data analysis plan.
Acute glucose response to an AST at a blood glucose level of approximately 250 milligrams per deciliter (mg/dL).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 29Population: All participants in Part A who received 60 mg LY2409021 and had an evaluable glucagon response at Baseline and on Day 29.
Acute glucagon response to an AST at a blood glucose level of approximately 250 mg/dL.
Outcome measures
| Measure |
Placebo - Healthy (Part A)
n=5 Participants
Placebo administered orally, QD for 28 days to healthy participants.
|
60 mg LY2409021 - Healthy (Part A)
n=7 Participants
60 mg LY2409021 administered orally, QD for 28 days to healthy participants.
|
Placebo - T2DM (Parts A and B)
Placebo administered orally, QD for 28 days to participants with T2DM.
|
15 mg LY2409021 - T2DM (Part B)
15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
60 mg LY2409021 - T2DM (Part A)
60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
|---|---|---|---|---|---|
|
Change From Baseline to Day 29 in Glucagon Response to an Arginine Stimulation Test (AST) (Part A)
|
80.0 pmol/L
Interval 42.2 to 118.0
|
103 pmol/L
Interval 79.5 to 126.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 29Population: All participants in Part A who received 60 mg LY2409021 and had an evaluable insulin response at Baseline and on Day 29.
Acute insulin response to an AST at a blood glucose level of approximately 250 mg/dL.
Outcome measures
| Measure |
Placebo - Healthy (Part A)
n=5 Participants
Placebo administered orally, QD for 28 days to healthy participants.
|
60 mg LY2409021 - Healthy (Part A)
n=7 Participants
60 mg LY2409021 administered orally, QD for 28 days to healthy participants.
|
Placebo - T2DM (Parts A and B)
Placebo administered orally, QD for 28 days to participants with T2DM.
|
15 mg LY2409021 - T2DM (Part B)
15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
60 mg LY2409021 - T2DM (Part A)
60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
|---|---|---|---|---|---|
|
Change From Baseline to Day 29 in Insulin Response to an Arginine Stimulation Test (AST) (Part A)
|
-34.7 pmol/L
Interval -207.0 to 138.0
|
139 pmol/L
Interval -73.6 to 352.0
|
—
|
—
|
—
|
Adverse Events
Placebo - Healthy (Part A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
60 mg LY2409021 - Healthy (Part A)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo - T2DM (Parts A and B)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
15 mg LY2409021 - T2DM (Part B)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
60 mg LY2409021 - T2DM (Part A)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo - Healthy (Part A)
n=2 participants at risk
Placebo administered orally, QD for 28 days to healthy participants.
|
60 mg LY2409021 - Healthy (Part A)
n=7 participants at risk
60 mg LY2409021 administered orally, QD for 28 days to healthy participants.
|
Placebo - T2DM (Parts A and B)
n=5 participants at risk
Placebo administered orally, QD for 28 days to participants with T2DM.
|
15 mg LY2409021 - T2DM (Part B)
n=9 participants at risk
15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
60 mg LY2409021 - T2DM (Part A)
n=7 participants at risk
60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/2
|
0.00%
0/7
|
0.00%
0/5
|
11.1%
1/9 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2
|
0.00%
0/7
|
0.00%
0/5
|
11.1%
1/9 • Number of events 1
|
0.00%
0/7
|
Other adverse events
| Measure |
Placebo - Healthy (Part A)
n=2 participants at risk
Placebo administered orally, QD for 28 days to healthy participants.
|
60 mg LY2409021 - Healthy (Part A)
n=7 participants at risk
60 mg LY2409021 administered orally, QD for 28 days to healthy participants.
|
Placebo - T2DM (Parts A and B)
n=5 participants at risk
Placebo administered orally, QD for 28 days to participants with T2DM.
|
15 mg LY2409021 - T2DM (Part B)
n=9 participants at risk
15 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
60 mg LY2409021 - T2DM (Part A)
n=7 participants at risk
60 mg LY2409021 administered orally, QD for 28 days to participants with T2DM.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/2
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
0.00%
0/9
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
11.1%
1/9 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/9
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2
|
0.00%
0/7
|
0.00%
0/5
|
11.1%
1/9 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2
|
0.00%
0/7
|
0.00%
0/5
|
11.1%
1/9 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Asthenia
|
0.00%
0/2
|
0.00%
0/7
|
0.00%
0/5
|
11.1%
1/9 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Catheter site erythema
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Catheter site haematoma
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
33.3%
3/9 • Number of events 3
|
28.6%
2/7 • Number of events 3
|
|
General disorders
Catheter site pain
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/7
|
|
General disorders
Catheter site swelling
|
0.00%
0/2
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
0.00%
0/9
|
0.00%
0/7
|
|
General disorders
Fatigue
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/2
|
0.00%
0/7
|
0.00%
0/5
|
11.1%
1/9 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Pyrexia
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/9
|
0.00%
0/7
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/2
|
0.00%
0/7
|
20.0%
1/5 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/2
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
0.00%
0/9
|
0.00%
0/7
|
|
Infections and infestations
Influenza
|
0.00%
0/2
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/9
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
0.00%
0/9
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/2
|
0.00%
0/7
|
0.00%
0/5
|
11.1%
1/9 • Number of events 1
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/2
|
0.00%
0/7
|
0.00%
0/5
|
11.1%
1/9 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/2
|
28.6%
2/7 • Number of events 2
|
0.00%
0/5
|
11.1%
1/9 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/2
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/9
|
42.9%
3/7 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2
|
14.3%
1/7 • Number of events 3
|
0.00%
0/5
|
11.1%
1/9 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
0.00%
0/9
|
0.00%
0/7
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/2
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
0.00%
0/9
|
0.00%
0/7
|
|
Nervous system disorders
Headache
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/2
|
0.00%
0/7
|
0.00%
0/5
|
11.1%
1/9 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/7
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/9
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/9
|
28.6%
2/7 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
0.00%
0/9
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2
|
0.00%
0/7
|
0.00%
0/5
|
11.1%
1/9 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Blister
|
50.0%
1/2 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/2
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
0.00%
0/9
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2
|
14.3%
1/7 • Number of events 2
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place