Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity (NCT NCT05696847)
NCT ID: NCT05696847
Last Updated: 2025-08-26
Results Overview
Percentage of participants with TEAEs and SAEs were reported here. A summary of TEAEs, SAEs and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events section of this record.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Baseline through Week 14
Results posted on
2025-08-26
Participant Flow
Participant milestones
| Measure |
Cohort 1: Placebo (BW >=50 kg)
Participants in this cohort had a screening body weight (BW) of at least 50 kilograms (kg) received placebo administered subcutaneously (SC) once weekly (QW) during Weeks 1 to 8.
|
Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)
Participants in this cohort had a screening body weight of at least 50 kg received 2.5 milligrams (mg) tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
|
Cohort 2: Placebo (BW <50 kg)
Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8.
|
Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)
Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8.
|
Cohort 3: Placebo (BW 40 to 60 kg)
Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8.
|
Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
2
|
7
|
3
|
7
|
|
Overall Study
Received At Least One Dose of Study Drug
|
2
|
6
|
2
|
7
|
3
|
7
|
|
Overall Study
COMPLETED
|
2
|
5
|
2
|
6
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1: Placebo (BW >=50 kg)
Participants in this cohort had a screening body weight (BW) of at least 50 kilograms (kg) received placebo administered subcutaneously (SC) once weekly (QW) during Weeks 1 to 8.
|
Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)
Participants in this cohort had a screening body weight of at least 50 kg received 2.5 milligrams (mg) tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
|
Cohort 2: Placebo (BW <50 kg)
Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8.
|
Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)
Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8.
|
Cohort 3: Placebo (BW 40 to 60 kg)
Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8.
|
Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Parent/Guardian
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity
Baseline characteristics by cohort
| Measure |
Cohort 1: Placebo (BW >=50 kg)
n=2 Participants
Participants in this cohort had a screening body weight of at least 50 kg received placebo administered SC QW during Weeks 1 to 8.
|
Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)
n=6 Participants
Participants in this cohort had a screening body weight of at least 50 kg received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
|
Cohort 2: Placebo (BW <50 kg)
n=2 Participants
Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8.
|
Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)
n=7 Participants
Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8.
|
Cohort 3: Placebo (BW 40 to 60 kg)
n=3 Participants
Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8.
|
Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
n=7 Participants
Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
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=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
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=10 Participants
|
0 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
22 Participants
n=115 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=10 Participants
|
0 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
13 Participants
n=115 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=10 Participants
|
0 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 14Population: All participants who received at least one dose of study drug.
Percentage of participants with TEAEs and SAEs were reported here. A summary of TEAEs, SAEs and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events section of this record.
Outcome measures
| Measure |
Cohort 1: Placebo (BW >=50 kg)
n=2 Participants
Participants in this cohort had a screening body weight of at least 50 kg received placebo administered SC QW during Weeks 1 to 8.
|
Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)
n=6 Participants
Participants in this cohort had a screening body weight of at least 50 kg received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
|
Cohort 2: Placebo (BW <50 kg)
n=2 Participants
Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8.
|
Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)
n=7 Participants
Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8.
|
Cohort 3: Placebo (BW 40 to 60 kg)
n=3 Participants
Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8.
|
Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
n=7 Participants
Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)
TEAE
|
0.0 Percentage of participants
|
83.3 Percentage of participants
|
0.0 Percentage of participants
|
85.7 Percentage of participants
|
33.3 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)
SAE
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Predose on weeks 3, 6, 8; 12 and 24 hours post first dose; Within 24 to 96 hours post-dose at week 4; Within 120 to 168 hours post-dose at week 6.Population: All participants who received at least one dose of tirzepatide and had evaluable PK data.
PK: AUC0-tau of tirzepatide was reported.
Outcome measures
| Measure |
Cohort 1: Placebo (BW >=50 kg)
n=6 Participants
Participants in this cohort had a screening body weight of at least 50 kg received placebo administered SC QW during Weeks 1 to 8.
|
Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)
n=7 Participants
Participants in this cohort had a screening body weight of at least 50 kg received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
|
Cohort 2: Placebo (BW <50 kg)
n=7 Participants
Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8.
|
Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)
Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8.
|
Cohort 3: Placebo (BW 40 to 60 kg)
Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8.
|
Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of Tirzepatide
|
105000 nanogram *hour per milliliter (ng*h/mL)
Standard Deviation 33100
|
80800 nanogram *hour per milliliter (ng*h/mL)
Standard Deviation 9580
|
156000 nanogram *hour per milliliter (ng*h/mL)
Standard Deviation 22500
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose on weeks 3, 6, 8; 12 and 24 hours post first dose; Within 24 to 96 hours post-dose at week 4; Within 120 to 168 hours post-dose at week 6.Population: All participants who received at least one dose of tirzepatide and had evaluable PK data.
PK: Cmax of tirzepatide
Outcome measures
| Measure |
Cohort 1: Placebo (BW >=50 kg)
n=6 Participants
Participants in this cohort had a screening body weight of at least 50 kg received placebo administered SC QW during Weeks 1 to 8.
|
Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)
n=7 Participants
Participants in this cohort had a screening body weight of at least 50 kg received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
|
Cohort 2: Placebo (BW <50 kg)
n=7 Participants
Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8.
|
Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)
Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8.
|
Cohort 3: Placebo (BW 40 to 60 kg)
Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8.
|
Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
|
|---|---|---|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of Tirzepatide
|
884 nanograms per milliliter (ng/mL)
Standard Deviation 243
|
674 nanograms per milliliter (ng/mL)
Standard Deviation 63.8
|
1280 nanograms per milliliter (ng/mL)
Standard Deviation 194
|
—
|
—
|
—
|
Adverse Events
Cohort 1: Placebo (BW >=50 kg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2: Placebo (BW <50 kg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 3: Placebo (BW 40 to 60 kg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: Placebo (BW >=50 kg)
n=2 participants at risk
Participants in this cohort had a screening body weight of at least 50 kilograms (kg) received placebo administered subcutaneously (SC) once weekly (QW) in Weeks 1 to 8.
|
Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)
n=6 participants at risk
Participants in this cohort had a screening body weight of at least 50 kg received 2.5 milligrams (mg) tirzepatide administered SC QW in Weeks 1 to 4 followed by 5 mg tirzepatide in Weeks 5 to 8.
|
Cohort 2: Placebo (BW <50 kg)
n=2 participants at risk
Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW in Weeks 1 to 8.
|
Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)
n=7 participants at risk
Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW in Weeks 1 to 4 followed by 2.5 mg tirzepatide in Weeks 5 to 8.
|
Cohort 3: Placebo (BW 40 to 60 kg)
n=3 participants at risk
Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW in Weeks 1 to 8.
|
Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
n=7 participants at risk
Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW in Weeks 1 to 4 followed by 5 mg tirzepatide in Weeks 5 to 8.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
33.3%
1/3 • Number of events 5 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
57.1%
4/7 • Number of events 9 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
33.3%
2/6 • Number of events 2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
33.3%
1/3 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
42.9%
3/7 • Number of events 7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
50.0%
3/6 • Number of events 3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
28.6%
2/7 • Number of events 2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
71.4%
5/7 • Number of events 7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
16.7%
1/6 • Number of events 2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
85.7%
6/7 • Number of events 11 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
General disorders
Fatigue
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
General disorders
Injection site erythema
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
General disorders
Injection site reaction
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
33.3%
1/3 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Otitis media
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
33.3%
1/3 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
50.0%
3/6 • Number of events 3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
33.3%
1/3 • Number of events 2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/6 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/2 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/7 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/3 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
14.3%
1/7 • Number of events 1 • Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60