Trial Outcomes & Findings for A Study of LY3493269 in Healthy Participants (NCT NCT04682106)
NCT ID: NCT04682106
Last Updated: 2025-01-14
Results Overview
TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. A summary of serious adverse events (SAEs), TEAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Adverse Events section of this record.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Baseline through Day 44
Results posted on
2025-01-14
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo orally once daily (QD) for three consecutive days.
|
8 Milligrams (mg) LY3493269 + 600 mg Salcaprozate Sodium (SNAC)
Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
|
24 mg LY3493269 + 600 mg SNAC
Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
|
12 mg LY3493269 + 300 mg SNAC
Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
|
4 mg LY3493269 + 300 mg SNAC
Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
Received at Least One Dose of Study Drug
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY3493269 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
Participants received placebo orally QD for three consecutive days.
|
8 mg LY3493269 + 600 mg SNAC
n=8 Participants
Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
|
24 mg LY3493269 + 600 mg SNAC
n=8 Participants
Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
|
12 mg LY3493269 + 300 mg SNAC
n=8 Participants
Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
|
4 mg LY3493269 + 300 mg SNAC
n=8 Participants
Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.9 Years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
39.1 Years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
45.5 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
44.4 Years
STANDARD_DEVIATION 6.7 • n=4 Participants
|
45.9 Years
STANDARD_DEVIATION 7.0 • n=21 Participants
|
44.0 Years
STANDARD_DEVIATION 8.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
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
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
40 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 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
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
40 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
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 44Population: All participants who received at least one dose of study drug.
TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. A summary of serious adverse events (SAEs), TEAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Adverse Events section of this record.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received placebo orally QD for three consecutive days.
|
8 mg LY3493269 + 600 mg SNAC
n=8 Participants
Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
|
24 mg LY3493269 + 600 mg SNAC
n=8 Participants
Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
|
12 mg LY3493269 + 300 mg SNAC
n=8 Participants
Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
|
4 mg LY3493269 + 300 mg SNAC
n=8 Participants
Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
|
|---|---|---|---|---|---|
|
Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs)
|
4 Participants
|
8 Participants
|
8 Participants
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dosePopulation: All enrolled participants who received at least one dose of LY3493269 and had at least one evaluable PK data.
PK: AUC (0-24) of LY3493269
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received placebo orally QD for three consecutive days.
|
8 mg LY3493269 + 600 mg SNAC
n=7 Participants
Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
|
24 mg LY3493269 + 600 mg SNAC
n=7 Participants
Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
|
12 mg LY3493269 + 300 mg SNAC
n=8 Participants
Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
|
4 mg LY3493269 + 300 mg SNAC
Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC [0-24]) of LY3493269
|
2960 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 137
|
9680 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 46
|
4850 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 146
|
1150 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 77
|
—
|
SECONDARY outcome
Timeframe: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dosePopulation: All enrolled participants who received at least one dose of LY3493269 and had at least one evaluable PK data.
PK: Cmax of LY3493269
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received placebo orally QD for three consecutive days.
|
8 mg LY3493269 + 600 mg SNAC
n=7 Participants
Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
|
24 mg LY3493269 + 600 mg SNAC
n=7 Participants
Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
|
12 mg LY3493269 + 300 mg SNAC
n=8 Participants
Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
|
4 mg LY3493269 + 300 mg SNAC
Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
|
|---|---|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of LY3493269
|
166 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 137
|
527 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 44
|
270 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 122
|
62.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 84
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
8 mg LY3493269 + 600 mg SNAC
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
24 mg LY3493269 + 600 mg SNAC
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
12 mg LY3493269 + 300 mg SNAC
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
4 mg LY3493269 + 300 mg SNAC
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 |
Placebo
n=8 participants at risk
Participants received placebo orally QD for three consecutive days.
|
8 mg LY3493269 + 600 mg SNAC
n=8 participants at risk
Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
|
24 mg LY3493269 + 600 mg SNAC
n=8 participants at risk
Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
|
12 mg LY3493269 + 300 mg SNAC
n=8 participants at risk
Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
|
4 mg LY3493269 + 300 mg SNAC
n=8 participants at risk
Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
62.5%
5/8 • Number of events 5 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
50.0%
4/8 • Number of events 4 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
25.0%
2/8 • Number of events 2 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
25.0%
2/8 • Number of events 2 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
62.5%
5/8 • Number of events 6 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
37.5%
3/8 • Number of events 5 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
50.0%
4/8 • Number of events 5 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
50.0%
4/8 • Number of events 11 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
62.5%
5/8 • Number of events 7 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
37.5%
3/8 • Number of events 39 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Catheter site bruise
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Catheter site erythema
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
62.5%
5/8 • Number of events 5 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
25.0%
2/8 • Number of events 2 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Catheter site pain
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
37.5%
3/8 • Number of events 3 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Catheter site swelling
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Medical device site erythema
|
25.0%
2/8 • Number of events 3 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
75.0%
6/8 • Number of events 8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
25.0%
2/8 • Number of events 2 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
25.0%
2/8 • Number of events 3 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Medical device site laceration
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Medical device site pruritus
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Pain
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Swelling face
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Ulcer
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Vessel puncture site bruise
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Investigations
Lipase increased
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Investigations
Weight decreased
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
50.0%
4/8 • Number of events 6 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
87.5%
7/8 • Number of events 8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
75.0%
6/8 • Number of events 6 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
50.0%
4/8 • Number of events 4 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 2 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
25.0%
2/8 • Number of events 2 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
37.5%
3/8 • Number of events 5 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
25.0%
2/8 • Number of events 2 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
37.5%
3/8 • Number of events 4 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 3 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
37.5%
3/8 • Number of events 3 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
25.0%
2/8 • Number of events 2 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 2 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
12.5%
1/8 • Number of events 1 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/8 • Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place