Trial Outcomes & Findings for A Study of LY3493269 in Participants With Type 2 Diabetes (NCT NCT04515576)
NCT ID: NCT04515576
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. An SAE is defined as any untoward medical occurrence that, at any dose: 1. Results in death 2. Is life-threatening 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent disability/incapacity 5. Is a congenital anomaly/birth defect 6. Other situations: Based on medical or scientific judgement. A summary of SAEs, TEAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
Baseline through final follow-up at Day 57
Results posted on
2025-01-14
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.
|
1.5 Milligrams (mg) Dulaglutide
Participants received 1.5 mg dulaglutide SC QW for 4 weeks.
|
0.3 mg LY3493269
Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.
|
1 mg LY3493269
Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks.
|
0.75/1.5/3 mg LY3493269
Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses.
|
1.5/3/4/5 mg LY3493269
Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
8
|
8
|
11
|
14
|
|
Overall Study
Received at Least One Dose of Study Drug
|
7
|
8
|
8
|
8
|
11
|
14
|
|
Overall Study
COMPLETED
|
7
|
8
|
8
|
8
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.
|
1.5 Milligrams (mg) Dulaglutide
Participants received 1.5 mg dulaglutide SC QW for 4 weeks.
|
0.3 mg LY3493269
Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.
|
1 mg LY3493269
Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks.
|
0.75/1.5/3 mg LY3493269
Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses.
|
1.5/3/4/5 mg LY3493269
Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of LY3493269 in Participants With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=7 Participants
Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.
|
1.5 mg Dulaglutide
n=8 Participants
Participants received 1.5 mg dulaglutide SC QW for 4 weeks.
|
0.3 mg LY3493269
n=8 Participants
Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.
|
1 mg LY3493269
n=8 Participants
Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks
|
0.75/1.5/3 mg LY3493269
n=11 Participants
Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses.
|
1.5/3/4/5 mg LY3493269
n=14 Participants
Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
60.9 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 3.4 • n=4 Participants
|
55.1 years
STANDARD_DEVIATION 5.3 • n=21 Participants
|
59.9 years
STANDARD_DEVIATION 6.9 • n=8 Participants
|
59.2 years
STANDARD_DEVIATION 6.3 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
46 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
10 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
|
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
50 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 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
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
56 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline through final follow-up at Day 57Population: 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. An SAE is defined as any untoward medical occurrence that, at any dose: 1. Results in death 2. Is life-threatening 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent disability/incapacity 5. Is a congenital anomaly/birth defect 6. Other situations: Based on medical or scientific judgement. A summary of SAEs, TEAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.
|
1.5 mg Dulaglutide
n=8 Participants
Participants received 1.5 mg dulaglutide SC QW for 4 weeks.
|
0.3 mg LY3493269
n=8 Participants
Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.
|
1 mg LY3493269
n=8 Participants
Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks.
|
0.75/1.5/3 mg LY3493269
n=11 Participants
Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses.
|
1.5/3/4/5 mg LY3493269
n=14 Participants
Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses.
|
|---|---|---|---|---|---|---|
|
Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
TEAEs Related to Study Drug Administration
|
2 Participants
|
5 Participants
|
3 Participants
|
7 Participants
|
10 Participants
|
13 Participants
|
|
Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
SAEs Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.Population: All participants who received at least one dose of LY3493269 and had evaluable PK data.
Area Under the Concentration Versus Time Curve from Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.
|
1.5 mg Dulaglutide
n=8 Participants
Participants received 1.5 mg dulaglutide SC QW for 4 weeks.
|
0.3 mg LY3493269
n=11 Participants
Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.
|
1 mg LY3493269
n=11 Participants
Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks.
|
0.75/1.5/3 mg LY3493269
Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses.
|
1.5/3/4/5 mg LY3493269
Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269
Week 1
|
4220 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 27
|
18500 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 40
|
10200 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 30
|
22800 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 25
|
—
|
—
|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269
Week 4
|
10600 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 21
|
38500 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 25
|
105000 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 27
|
123000 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 22
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.Population: All participants who received at least one dose of LY3493269 and had evaluable PK data.
Maximum Observed Drug Concentration (Cmax) of LY3493269
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.
|
1.5 mg Dulaglutide
n=8 Participants
Participants received 1.5 mg dulaglutide SC QW for 4 weeks.
|
0.3 mg LY3493269
n=11 Participants
Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.
|
1 mg LY3493269
n=14 Participants
Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks.
|
0.75/1.5/3 mg LY3493269
Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses.
|
1.5/3/4/5 mg LY3493269
Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses.
|
|---|---|---|---|---|---|---|
|
PK: Maximum Observed Drug Concentration (Cmax) of LY3493269
Week 1
|
31.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
153 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
73.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
165 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 34
|
—
|
—
|
|
PK: Maximum Observed Drug Concentration (Cmax) of LY3493269
Week 4
|
80.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
287 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 26
|
818 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
920 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 29Population: All participants who received at least one dose of study drug and had evaluable fasting plasma glucose data.
Pharmacodynamics (PD): Summary Statistics (Mean, Standard Deviation) of Change From Baseline to Day 29.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.
|
1.5 mg Dulaglutide
n=8 Participants
Participants received 1.5 mg dulaglutide SC QW for 4 weeks.
|
0.3 mg LY3493269
n=8 Participants
Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.
|
1 mg LY3493269
n=8 Participants
Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks.
|
0.75/1.5/3 mg LY3493269
n=11 Participants
Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses.
|
1.5/3/4/5 mg LY3493269
n=13 Participants
Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses.
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD):Change From Baseline to Day 29 in Fasting Plasma Glucose
|
-1.07 millimoles per litre (mmol/L)
Standard Deviation 2.34
|
-4.11 millimoles per litre (mmol/L)
Standard Deviation 2.82
|
-2.20 millimoles per litre (mmol/L)
Standard Deviation 1.47
|
-4.83 millimoles per litre (mmol/L)
Standard Deviation 2.75
|
-3.61 millimoles per litre (mmol/L)
Standard Deviation 3.29
|
-3.98 millimoles per litre (mmol/L)
Standard Deviation 3.11
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1.5 mg Dulaglutide QW
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
0.3 mg LY3493269 QW
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
1 mg LY3493269 QW
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
0.75/1.5/3 mg LY3493269 QW
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
1.5/3/4/5 mg LY3493269 QW
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=7 participants at risk
Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.
|
1.5 mg Dulaglutide QW
n=8 participants at risk
Participants received 1.5 mg dulaglutide SC QW for 4 weeks.
|
0.3 mg LY3493269 QW
n=8 participants at risk
Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.
|
1 mg LY3493269 QW
n=8 participants at risk
Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks.
|
0.75/1.5/3 mg LY3493269 QW
n=11 participants at risk
Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses.
|
1.5/3/4/5 mg LY3493269 QW
n=14 participants at risk
Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
37.5%
3/8 • Number of events 4 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
75.0%
6/8 • Number of events 8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
18.2%
2/11 • Number of events 2 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
28.6%
4/14 • Number of events 5 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 3 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 3 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 2 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 2 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
36.4%
4/11 • Number of events 6 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
35.7%
5/14 • Number of events 5 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
87.5%
7/8 • Number of events 15 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
27.3%
3/11 • Number of events 3 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
28.6%
4/14 • Number of events 5 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
37.5%
3/8 • Number of events 3 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
50.0%
4/8 • Number of events 6 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
27.3%
3/11 • Number of events 3 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
35.7%
5/14 • Number of events 9 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
21.4%
3/14 • Number of events 9 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
General disorders
Early satiety
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
36.4%
4/11 • Number of events 4 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
General disorders
Medical device site dermatitis
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 2 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 4 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
General disorders
Tenderness
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 2 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 3 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
62.5%
5/8 • Number of events 5 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
27.3%
3/11 • Number of events 4 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
57.1%
8/14 • Number of events 8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
18.2%
2/11 • Number of events 2 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 2 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 2 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
28.6%
2/7 • Number of events 4 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
45.5%
5/11 • Number of events 6 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
28.6%
4/14 • Number of events 4 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
37.5%
3/8 • Number of events 3 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
63.6%
7/11 • Number of events 7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
50.0%
7/14 • Number of events 8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Withdrawal hypertension
|
0.00%
0/7 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through final follow-up at Day 57
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60