Trial Outcomes & Findings for A Study of LY2944876 in Healthy Japanese and Non-Japanese Participants (NCT NCT02188303)
NCT ID: NCT02188303
Last Updated: 2021-05-27
Results Overview
An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Pre-dose (PRD) through Study Completion (Up to Day 40)
Results posted on
2021-05-27
Participant Flow
Participant milestones
| Measure |
Part A / Cohorts 1-3 - Placebo
Placebo, Single Dose Administered Subcutaneously (SC) on Day 1
|
Part A / Cohort 1 - 10 mg LY2944876
10 milligram (mg) LY2944876, Single Dose Administered SC on Day 1
|
Part A / Cohort 2 - 30 mg LY2944876
30 mg LY2944876, Single Dose Administered SC on Day 1
|
Part A / Cohort 3 - 50 mg LY2944876
50 mg LY2944876, Single Dose Administered SC on Day 1
|
Part B / Cohort 4 - Placebo
Placebo Administered Once Daily (QD) SC, Days 1-7
|
Part B / Cohort 4 - 40 mg LY2944876
40 mg LY2944876 Administered QD SC, Days 1-7
|
Part B / Cohort 5 - Placebo
Placebo Administered QD SC, Day 1, 4 and 6.
|
Part B / Cohort 5 - 15-60 mg Titrated LY2944876
LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
4
|
12
|
2
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
4
|
10
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
6
|
Reasons for withdrawal
| Measure |
Part A / Cohorts 1-3 - Placebo
Placebo, Single Dose Administered Subcutaneously (SC) on Day 1
|
Part A / Cohort 1 - 10 mg LY2944876
10 milligram (mg) LY2944876, Single Dose Administered SC on Day 1
|
Part A / Cohort 2 - 30 mg LY2944876
30 mg LY2944876, Single Dose Administered SC on Day 1
|
Part A / Cohort 3 - 50 mg LY2944876
50 mg LY2944876, Single Dose Administered SC on Day 1
|
Part B / Cohort 4 - Placebo
Placebo Administered Once Daily (QD) SC, Days 1-7
|
Part B / Cohort 4 - 40 mg LY2944876
40 mg LY2944876 Administered QD SC, Days 1-7
|
Part B / Cohort 5 - Placebo
Placebo Administered QD SC, Day 1, 4 and 6.
|
Part B / Cohort 5 - 15-60 mg Titrated LY2944876
LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
2
|
|
Overall Study
Dose Termination Criteria Met
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
4
|
Baseline Characteristics
Age data was presented per Cohort (Part A and Part B).
Baseline characteristics by cohort
| Measure |
Part A / Cohorts 1-3 - Placebo
n=6 Participants
Placebo, Single Dose Administered SC
|
Part A / Cohort 1 - 10 mg LY2944876
n=6 Participants
LY2944876 10 mg, Single Dose Administered SC
|
Part A / Cohort 2 - 30 mg LY2944876
n=6 Participants
LY2944876 30 mg, Single Dose Administered SC
|
Part A / Cohort 3 - 50 mg LY2944876
n=6 Participants
LY2944876 50 mg, Single Dose Administered SC
|
Part B / Cohort 4 - Placebo
n=4 Participants
Placebo Administered QD SC, Days 1-7
|
Part B / Cohort 4 - 40 mg LY2944876
n=12 Participants
LY2944876 40 mg, Administered QD SC, Days 1-7
|
Part B / Cohort 5 - Placebo
n=2 Participants
Placebo, Administered QD SC, Days 1, 4 and 6.
|
Part B / Cohort 5 - 15-60 mg Titrated LY2944876
n=6 Participants
LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Cohorts 1-3
|
29.2 Years
STANDARD_DEVIATION 5.4 • n=6 Participants • Age data was presented per Cohort (Part A and Part B).
|
33.2 Years
STANDARD_DEVIATION 5.8 • n=6 Participants • Age data was presented per Cohort (Part A and Part B).
|
29.5 Years
STANDARD_DEVIATION 3.9 • n=6 Participants • Age data was presented per Cohort (Part A and Part B).
|
29.2 Years
STANDARD_DEVIATION 3.5 • n=6 Participants • Age data was presented per Cohort (Part A and Part B).
|
—
|
—
|
—
|
—
|
30.3 Years
STANDARD_DEVIATION 4.8 • n=24 Participants • Age data was presented per Cohort (Part A and Part B).
|
|
Age, Continuous
Cohorts 4-5
|
—
|
—
|
—
|
—
|
47.5 Years
STANDARD_DEVIATION 18.2 • n=4 Participants • Age data was presented per Cohort (Part A and Part B).
|
46.3 Years
STANDARD_DEVIATION 16.4 • n=12 Participants • Age data was presented per Cohort (Part A and Part B).
|
56.5 Years
STANDARD_DEVIATION 7.8 • n=2 Participants • Age data was presented per Cohort (Part A and Part B).
|
46.3 Years
STANDARD_DEVIATION 16.6 • n=6 Participants • Age data was presented per Cohort (Part A and Part B).
|
47.3 Years
STANDARD_DEVIATION 15.6 • n=24 Participants • Age data was presented per Cohort (Part A and Part B).
|
|
Sex: Female, Male
Female
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=12 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=6 Participants
|
8 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=12 Participants
|
1 Participants
n=2 Participants
|
4 Participants
n=6 Participants
|
40 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
25 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=12 Participants
|
2 Participants
n=2 Participants
|
6 Participants
n=6 Participants
|
23 Participants
n=48 Participants
|
|
Region of Enrollment
United Kingdom
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=12 Participants
|
2 Participants
n=2 Participants
|
6 Participants
n=6 Participants
|
48 Participants
n=48 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (PRD) through Study Completion (Up to Day 40)Population: All enrolled participants, whether or not they completed all protocol requirements.
An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
Outcome measures
| Measure |
Cohorts 1-3 - Placebo
n=6 Participants
Placebo, Single Dose Administered SC
|
Cohort 1 - 10 mg LY2944876
n=6 Participants
10 mg LY2944876, Single Dose Administered SC
|
Cohort 2 - 30 mg LY2944876
n=6 Participants
30 mg LY2944876, Single Dose Administered SC
|
Cohort 3 - 50 mg LY2944876
n=6 Participants
50 mg LY2944876, Single Dose Administered SC
|
Cohort 4 - Placebo
n=4 Participants
Placebo Administered QD SC, Days 1-7
|
Cohort 4 - 40 mg LY2944876
n=12 Participants
40 mg LY2944876 Administered QD SC, Days 1-7
|
Cohort 5 - Placebo
n=2 Participants
Placebo Administered QD SC, Day 1, Day 4 and Day 6.
|
Cohort 5 - 15-60 mg Titrated LY2944876
n=6 Participants
LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to Be Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cohorts1-3:Day1 PRD,8,12,24,32,48,56,72,96,168Hrs;Days15,28,42:Cohort4:Day1 PRD,12 Hrs;Days2,3,4,5,6 PRD;Day7 PRD,12,24,36,48,56,72,96,168 Hrs;Days21,34,49: Cohort 5:Day1 PRD,12,24,48 Hrs;Days4,6,8,10 PRD;Day12 PRD,12,24,36,48,56,72,96,168 Hrs;Day26,39,53Population: All randomized participants receiving at least one dose of the investigational product and had evaluable AUC data.
Outcome measures
| Measure |
Cohorts 1-3 - Placebo
n=6 Participants
Placebo, Single Dose Administered SC
|
Cohort 1 - 10 mg LY2944876
n=6 Participants
10 mg LY2944876, Single Dose Administered SC
|
Cohort 2 - 30 mg LY2944876
n=6 Participants
30 mg LY2944876, Single Dose Administered SC
|
Cohort 3 - 50 mg LY2944876
n=10 Participants
50 mg LY2944876, Single Dose Administered SC
|
Cohort 4 - Placebo
n=5 Participants
Placebo Administered QD SC, Days 1-7
|
Cohort 4 - 40 mg LY2944876
40 mg LY2944876 Administered QD SC, Days 1-7
|
Cohort 5 - Placebo
Placebo Administered QD SC, Day 1, Day 4 and Day 6.
|
Cohort 5 - 15-60 mg Titrated LY2944876
LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve - Time Zero to 168 Hours Post-dose [AUC(0-168h)] of LY2944876
|
105000 nanograms∙hours/milliliters (ng∙h/mL)
Geometric Coefficient of Variation 32
|
307000 nanograms∙hours/milliliters (ng∙h/mL)
Geometric Coefficient of Variation 38
|
495000 nanograms∙hours/milliliters (ng∙h/mL)
Geometric Coefficient of Variation 34
|
1789000 nanograms∙hours/milliliters (ng∙h/mL)
Geometric Coefficient of Variation 15
|
803000 nanograms∙hours/milliliters (ng∙h/mL)
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohorts1-3:Day1 PRD,8,12,24,32,48,56,72,96,168Hrs;Days15,28,42:Cohort4:Day1 PRD,12 Hrs;Days2,3,4,5,6 PRD;Day7 PRD,12,24,36,48,56,72,96,168 Hrs;Days21,34,49: Cohort 5:Day1 PRD,12,24,48 Hrs;Days4,6,8,10 PRD;Day12 PRD,12,24,36,48,56,72,96,168 Hrs;Day26,39,53Population: All randomized participants receiving at least one dose of the investigational product and had evaluable Cmax data.
Outcome measures
| Measure |
Cohorts 1-3 - Placebo
n=6 Participants
Placebo, Single Dose Administered SC
|
Cohort 1 - 10 mg LY2944876
n=6 Participants
10 mg LY2944876, Single Dose Administered SC
|
Cohort 2 - 30 mg LY2944876
n=6 Participants
30 mg LY2944876, Single Dose Administered SC
|
Cohort 3 - 50 mg LY2944876
n=10 Participants
50 mg LY2944876, Single Dose Administered SC
|
Cohort 4 - Placebo
n=5 Participants
Placebo Administered QD SC, Days 1-7
|
Cohort 4 - 40 mg LY2944876
40 mg LY2944876 Administered QD SC, Days 1-7
|
Cohort 5 - Placebo
Placebo Administered QD SC, Day 1, Day 4 and Day 6.
|
Cohort 5 - 15-60 mg Titrated LY2944876
LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY2944876
|
790 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
2360 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
3640 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
11700 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 26
|
5470 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
Adverse Events
Cohorts 1-3 - Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 1 - LY2944876 10 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2 - LY2944876 30 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3 - LY2944876 50 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 4 - Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 4 - LY2944876 40 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 5 - Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 5 - 15-80 mg Titrated LY2944876
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohorts 1-3 - Placebo
n=6 participants at risk
Placebo, Single Dose Administered Subcutaneously (SC)
|
Cohort 1 - LY2944876 10 mg
n=6 participants at risk
LY2944876 10 mg, Single Dose Administered SC
|
Cohort 2 - LY2944876 30 mg
n=6 participants at risk
LY2944876 30 mg, Single Dose Administered SC
|
Cohort 3 - LY2944876 50 mg
n=6 participants at risk
LY2944876 50 mg, Single Dose Administered SC
|
Cohort 4 - Placebo
n=4 participants at risk
Placebo Administered QD SC, Days 1-7
|
Cohort 4 - LY2944876 40 mg
n=12 participants at risk
LY2944876 40 mg Administered QD SC, Days 1-7
|
Cohort 5 - Placebo
n=2 participants at risk
Placebo Administered QD SC, Day 1, Day 4, and Day 6.
|
Cohort 5 - 15-80 mg Titrated LY2944876
n=6 participants at risk
LY2944876 Administered QD SC 15 mg on Day 1, 30 mg on Day 4 and up to 60 mg on Day 6.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
83.3%
5/6 • Number of events 6
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/12
|
50.0%
1/2 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/12
|
0.00%
0/2
|
16.7%
1/6 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
8.3%
1/12 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
25.0%
3/12 • Number of events 3
|
0.00%
0/2
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
|
0.00%
0/6
|
66.7%
4/6 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
50.0%
6/12 • Number of events 6
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
2/12 • Number of events 2
|
0.00%
0/2
|
33.3%
2/6 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/4
|
25.0%
3/12 • Number of events 3
|
0.00%
0/2
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/12
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/12
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
50.0%
6/12 • Number of events 6
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/12
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
0.00%
0/4
|
50.0%
6/12 • Number of events 6
|
50.0%
1/2 • Number of events 1
|
83.3%
5/6 • Number of events 5
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/12
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/4
|
66.7%
8/12 • Number of events 8
|
0.00%
0/2
|
50.0%
3/6 • Number of events 3
|
|
General disorders
Fatigue
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/12
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Feeling hot
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Injection site bruising
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
0.00%
0/2
|
16.7%
1/6 • Number of events 2
|
|
General disorders
Injection site pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/12
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Malaise
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/12
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
50.0%
3/6 • Number of events 3
|
0.00%
0/4
|
75.0%
9/12 • Number of events 9
|
0.00%
0/2
|
50.0%
3/6 • Number of events 3
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/6
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/12
|
50.0%
1/2 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/6
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
50.0%
2/4 • Number of events 2
|
8.3%
1/12 • Number of events 2
|
0.00%
0/2
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
0.00%
0/2
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Joint lock
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/12
|
0.00%
0/2
|
33.3%
2/6 • Number of events 2
|
|
Nervous system disorders
Ageusia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/12
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
25.0%
3/12 • Number of events 3
|
0.00%
0/2
|
50.0%
3/6 • Number of events 3
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
50.0%
6/12 • Number of events 7
|
50.0%
1/2 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/6
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
16.7%
2/12 • Number of events 2
|
0.00%
0/2
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/12
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/12
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60