Trial Outcomes & Findings for A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) (NCT NCT03976401)
NCT ID: NCT03976401
Last Updated: 2022-08-04
Results Overview
Main study. ANCOVA multiple imputation with treatment group and F1 fibrosis score (F1 vs F2-3) as factors and baseline hepatic fat fraction measured by MRI-PDFF as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-08-04
Participant Flow
Participant milestones
| Measure |
Main Study EFX 28 mg
QW SC injection for 16 weeks.
|
Main Study EFX 50 mg
QW SC injection for 16 weeks.
|
Main Study EFX 70 mg
QW SC injection for 16 weeks.
|
Main Study Placebo
QW SC injection for 16 weeks.
|
Cohort C EFX 50 mg
QW SC injection for 16 weeks.
|
Cohort C Placebo
QW SC injection for 16 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
20
|
21
|
20
|
10
|
|
Overall Study
COMPLETED
|
16
|
16
|
15
|
19
|
19
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
5
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Main Study EFX 28 mg
QW SC injection for 16 weeks.
|
Main Study EFX 50 mg
QW SC injection for 16 weeks.
|
Main Study EFX 70 mg
QW SC injection for 16 weeks.
|
Main Study Placebo
QW SC injection for 16 weeks.
|
Cohort C EFX 50 mg
QW SC injection for 16 weeks.
|
Cohort C Placebo
QW SC injection for 16 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
4
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrew Consent
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
Baseline characteristics by cohort
| Measure |
Main EFX 28 mg
n=19 Participants
Main Study
EFX: Administered by subcutaneous injection
|
Main EFX 50 mg
n=20 Participants
Main Study
EFX: Administered by subcutaneous injection
|
Main EFX 70 mg
n=20 Participants
Main Study
EFX: Administered by subcutaneous injection
|
Main Placebo
n=21 Participants
Main Study
Placebo: Administered by subcutaneous injection
|
Cohort C EFX 50 mg
n=20 Participants
Cohort C
EFX: Administered by subcutaneous injection
|
Cohort C Placebo
n=10 Participants
Cohort C
Placebo: Administered by subcutaneous injection
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 12.40 • n=93 Participants
|
52.6 years
STANDARD_DEVIATION 14.19 • n=4 Participants
|
53.0 years
STANDARD_DEVIATION 13.22 • n=27 Participants
|
52.4 years
STANDARD_DEVIATION 9.57 • n=483 Participants
|
61.1 years
STANDARD_DEVIATION 10.0 • n=36 Participants
|
57.1 years
STANDARD_DEVIATION 14.4 • n=10 Participants
|
54.4 years
STANDARD_DEVIATION 12.3 • n=115 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
65 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
45 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
53 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
57 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
18 Participants
n=36 Participants
|
10 Participants
n=10 Participants
|
103 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=93 Participants
|
20 participants
n=4 Participants
|
20 participants
n=27 Participants
|
21 participants
n=483 Participants
|
20 participants
n=36 Participants
|
10 participants
n=10 Participants
|
110 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set (all randomized subjects)
Main study. ANCOVA multiple imputation with treatment group and F1 fibrosis score (F1 vs F2-3) as factors and baseline hepatic fat fraction measured by MRI-PDFF as a covariate.
Outcome measures
| Measure |
Main Study EFX 28 mg
n=19 Participants
QW SC injection for 16 weeks
|
Main Study EFX 50 mg
n=20 Participants
QW SC injection for 16 weeks
|
Main Study EFX 70 mg
n=20 Participants
QW SC injection for 16 weeks
|
Main Study Placebo
n=21 Participants
QW SC injection for 16 weeks
|
|---|---|---|---|---|
|
Main: Absolute Change From Baseline in Hepatic Fat Fraction Assessed by MRI-PDFF at Week 12.
|
-12.32 Absolute percentage of hepatic fat
Standard Error 1.04
|
-13.44 Absolute percentage of hepatic fat
Standard Error 1.04
|
-14.14 Absolute percentage of hepatic fat
Standard Error 1.04
|
-0.29 Absolute percentage of hepatic fat
Standard Error 0.98
|
SECONDARY outcome
Timeframe: 22-24 weeksPopulation: Subjects from Full Analysis Set with 30% or greater reduction in hepatic fat fraction at Week 12, who returned for MRI-PDFF
Main study. Included subjects with ≥30% relative fat reduction on MRI-PDFF at Week 12 that were required to return between Weeks 22 - 24. ANCOVA model with treatment group and F1 fibrosis score (F1 vs F2-3) as factors and baseline hepatic fat fraction as a covariate were performed.
Outcome measures
| Measure |
Main Study EFX 28 mg
n=16 Participants
QW SC injection for 16 weeks
|
Main Study EFX 50 mg
n=17 Participants
QW SC injection for 16 weeks
|
Main Study EFX 70 mg
n=15 Participants
QW SC injection for 16 weeks
|
Main Study Placebo
n=2 Participants
QW SC injection for 16 weeks
|
|---|---|---|---|---|
|
Main: Absolute Change From Baseline in Hepatic Fat Fraction Assessed by MRI-PDFF at Week 22-24.
|
-9.50 Absolute percentage of hepatic fat
Standard Error 1.49
|
-8.99 Absolute percentage of hepatic fat
Standard Error 1.49
|
-12.72 Absolute percentage of hepatic fat
Standard Error 1.50
|
-14.45 Absolute percentage of hepatic fat
Standard Error 4.08
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set (all randomized subjects)
Main study. ANCOVA multiple imputation with treatment group and F1 fibrosis score (F1 vs F2-3) as factors and baseline hepatic fat fraction measured by MRI-PDFF as a covariate.
Outcome measures
| Measure |
Main Study EFX 28 mg
n=19 Participants
QW SC injection for 16 weeks
|
Main Study EFX 50 mg
n=20 Participants
QW SC injection for 16 weeks
|
Main Study EFX 70 mg
n=20 Participants
QW SC injection for 16 weeks
|
Main Study Placebo
n=21 Participants
QW SC injection for 16 weeks
|
|---|---|---|---|---|
|
Main: Percent Change From Baseline in Hepatic Fat Fraction Measured by MRI-PDFF at Week 12.
|
-63.21 Percent change from baseline
Standard Error 5.01
|
-70.92 Percent change from baseline
Standard Error 4.97
|
-72.26 Percent change from baseline
Standard Error 5.04
|
-0.29 Percent change from baseline
Standard Error 4.55
|
SECONDARY outcome
Timeframe: 22-24 weeksPopulation: Subjects from Full Analysis Set with 30% or greater reduction in hepatic fat fraction at Week 12, who returned for MRI-PDFF
Main study. ANCOVA multiple imputation with treatment group and F1 fibrosis score (F1 vs F2-3) as factors and baseline hepatic fat fraction measured by MRI-PDFF as a covariate.
Outcome measures
| Measure |
Main Study EFX 28 mg
n=16 Participants
QW SC injection for 16 weeks
|
Main Study EFX 50 mg
n=17 Participants
QW SC injection for 16 weeks
|
Main Study EFX 70 mg
n=15 Participants
QW SC injection for 16 weeks
|
Main Study Placebo
n=2 Participants
QW SC injection for 16 weeks
|
|---|---|---|---|---|
|
Main: Percent Change From Baseline in Hepatic Fat Fraction Measured by MRI-PDFF at Week 22-24.
|
-49.80 Percent change from baseline
Standard Error 7.64
|
-43.37 Percent change from baseline
Standard Error 7.52
|
-63.70 Percent change from baseline
Standard Error 7.62
|
-69.87 Percent change from baseline
Standard Error 20.78
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set (all randomized subjects)
Main Study. The analyses included the treatment group and F1 fibrosis score (F1 vs F2-3) as factors and baseline hepatic fat fraction measured by MRI-PDFF as a covariate.
Outcome measures
| Measure |
Main Study EFX 28 mg
n=19 Participants
QW SC injection for 16 weeks
|
Main Study EFX 50 mg
n=20 Participants
QW SC injection for 16 weeks
|
Main Study EFX 70 mg
n=20 Participants
QW SC injection for 16 weeks
|
Main Study Placebo
n=21 Participants
QW SC injection for 16 weeks
|
|---|---|---|---|---|
|
Main: Responder: Subjects Who Achieved a Clinically Meaningful Relative Reduction of at Least 30% in Liver Fat Content as Measured by MRI-PDFF at Week 12.
|
16 Participants
|
17 Participants
|
15 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 22-24 weeksPopulation: Liver Biopsy Evaluable Analysis Set (subjects from Full Analysis Set with Baseline and Week 22-24 liver biopsy results)
Main study: Responders were defined for subjects with ≥ 30% relative fat reduction on MRI-PDFF at Week 12 and required to return between Weeks 22 - 24. Fisher's exact test was used for the analysis using the Full Analysis Set with missing values imputed as non-responders and repeated on Liver Biopsy Evaluable Analysis Set without imputation.
Outcome measures
| Measure |
Main Study EFX 28 mg
n=13 Participants
QW SC injection for 16 weeks
|
Main Study EFX 50 mg
n=13 Participants
QW SC injection for 16 weeks
|
Main Study EFX 70 mg
n=14 Participants
QW SC injection for 16 weeks
|
Main Study Placebo
n=2 Participants
QW SC injection for 16 weeks
|
|---|---|---|---|---|
|
Main: Responder Based on NAFLD Activity Score System (NAS): Subjects Who Had a Decrease of ≥2 Points in NAS With at Least a 1-point Reduction in Either Lobular Inflammation or Hepatocellular Ballooning and With no Concurrent Worsening of Fibrosis Stage.
|
10 Participants
|
10 Participants
|
11 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12, 16, and 20 weeksPopulation: Full Analysis Set (all randomized subjects)
ANCOVA model with treatment group, baseline hepatic fat fraction (\<15% vs ≥15%), and F1 fibrosis score (F1 vs F2-3) as factors and baseline value as a covariate.
Outcome measures
| Measure |
Main Study EFX 28 mg
n=19 Participants
QW SC injection for 16 weeks
|
Main Study EFX 50 mg
n=20 Participants
QW SC injection for 16 weeks
|
Main Study EFX 70 mg
n=20 Participants
QW SC injection for 16 weeks
|
Main Study Placebo
n=21 Participants
QW SC injection for 16 weeks
|
|---|---|---|---|---|
|
Main: Change From Baseline in ALT at Week 12, 16, and 20.
Change from Baseline to Week 16
|
-23.46 U/L
Standard Error 4.87
|
-31.99 U/L
Standard Error 4.59
|
-32.52 U/L
Standard Error 4.65
|
-3.17 U/L
Standard Error 4.42
|
|
Main: Change From Baseline in ALT at Week 12, 16, and 20.
Change from Baseline to Week 12
|
-24.46 U/L
Standard Error 3.76
|
-30.47 U/L
Standard Error 3.59
|
-32.29 U/L
Standard Error 3.59
|
-5.94 U/L
Standard Error 3.38
|
|
Main: Change From Baseline in ALT at Week 12, 16, and 20.
Change from Baseline to Week 20
|
-17.57 U/L
Standard Error 4.42
|
-21.20 U/L
Standard Error 4.17
|
-28.70 U/L
Standard Error 4.29
|
-4.29 U/L
Standard Error 3.96
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Full Analysis Set (all randomized subjects)
Cohort C: ANCOVA model with treatment group as a factor and baseline liver stiffness as evaluated by FibroScan® as a covariate using the Full Analysis Set. Missing values at Week 16 were imputed using the last-observed-carried-forward (LOCF) method.
Outcome measures
| Measure |
Main Study EFX 28 mg
n=20 Participants
QW SC injection for 16 weeks
|
Main Study EFX 50 mg
n=10 Participants
QW SC injection for 16 weeks
|
Main Study EFX 70 mg
QW SC injection for 16 weeks
|
Main Study Placebo
QW SC injection for 16 weeks
|
|---|---|---|---|---|
|
Cohort C: Change From Baseline in Liver Stiffness as Evaluated by FibroScan at Week 16
|
-37.6 KPa
Standard Error 8.6
|
12.1 KPa
Standard Error 12.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 12, 16, and 20 weeksPopulation: Full Analysis Set (all randomized subjects)
Cohort C. ANCOVA model with treatment group as a factor and baseline liver stiffness as evaluated by FibroScan® as a covariate using the Full Analysis Set. Missing values were imputed using the last-observed-carried-forward (LOCF) method.
Outcome measures
| Measure |
Main Study EFX 28 mg
n=20 Participants
QW SC injection for 16 weeks
|
Main Study EFX 50 mg
n=10 Participants
QW SC injection for 16 weeks
|
Main Study EFX 70 mg
QW SC injection for 16 weeks
|
Main Study Placebo
QW SC injection for 16 weeks
|
|---|---|---|---|---|
|
Cohort C: Change From Baseline in Non-invasive Biomarkers Including Pro-C3 at Week 12, 16, and 20.
Change from Baseline to Week 12
|
-8.4 ug/L
Standard Error 1.1
|
-2.8 ug/L
Standard Error 1.5
|
—
|
—
|
|
Cohort C: Change From Baseline in Non-invasive Biomarkers Including Pro-C3 at Week 12, 16, and 20.
Change from Baseline to Week 16
|
-9.0 ug/L
Standard Error 1.2
|
-3.4 ug/L
Standard Error 1.7
|
—
|
—
|
|
Cohort C: Change From Baseline in Non-invasive Biomarkers Including Pro-C3 at Week 12, 16, and 20.
Change from Baseline to Week 20
|
-5.2 ug/L
Standard Error 1.2
|
-4.9 ug/L
Standard Error 1.7
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 and 16 weeksPopulation: Full Analysis Set (all randomized subjects)
Cohort C. The enhanced liver fibrosis (ELF) score describes the severity of liver fibrosis where a score of \<7.7 indicates no or mild fibrosis, a score of ≥7.7 to \<9.8 indicates moderate fibrosis, and a score of ≥9.8 indicates severe fibrosis. A change from baseline with a negative value indicates a decrease in severity of liver fibrosis. An ANCOVA model with treatment group as a factor and baseline liver stiffness as evaluated by FibroScan® as a covariate using the Full Analysis Set was used. Missing values were imputed using the last-observed-carried-forward (LOCF) method.
Outcome measures
| Measure |
Main Study EFX 28 mg
n=20 Participants
QW SC injection for 16 weeks
|
Main Study EFX 50 mg
n=10 Participants
QW SC injection for 16 weeks
|
Main Study EFX 70 mg
QW SC injection for 16 weeks
|
Main Study Placebo
QW SC injection for 16 weeks
|
|---|---|---|---|---|
|
Cohort C: Change From Baseline in Non-invasive Biomarkers Including Liver Fibrosis by ELF Test Score at Week 12 and 16.
Change from Baseline to Week 12
|
-0.3 Score on a scale
Standard Error 0.2
|
0.3 Score on a scale
Standard Error 0.2
|
—
|
—
|
|
Cohort C: Change From Baseline in Non-invasive Biomarkers Including Liver Fibrosis by ELF Test Score at Week 12 and 16.
Change from Baseline to Week 16
|
-0.4 Score on a scale
Standard Error 0.1
|
0.3 Score on a scale
Standard Error 0.2
|
—
|
—
|
Adverse Events
Main Study EFX 28 mg
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Main Study EFX 50 mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Main Study EFX 70 mg
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Main Study Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Cohort C EFX 50 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Cohort C Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Main Study EFX 28 mg
n=19 participants at risk
QW SC injection for 16 weeks
|
Main Study EFX 50 mg
n=19 participants at risk
QW SC injection for 16 weeks
|
Main Study EFX 70 mg
n=20 participants at risk
QW SC injection for 16 weeks
|
Main Study Placebo
n=21 participants at risk
QW SC injection for 16 weeks
|
Cohort C EFX 50 mg
n=20 participants at risk
QW SC injection for 16 weeks
|
Cohort C Placebo
n=10 participants at risk
QW SC injection for 16 weeks
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
5.3%
1/19 • Number of events 1 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • Number of events 1 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
General disorders
Pyrexia
|
5.3%
1/19 • Number of events 1 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • Number of events 1 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
10.0%
1/10 • Number of events 1 • 20-24 weeks
|
Other adverse events
| Measure |
Main Study EFX 28 mg
n=19 participants at risk
QW SC injection for 16 weeks
|
Main Study EFX 50 mg
n=19 participants at risk
QW SC injection for 16 weeks
|
Main Study EFX 70 mg
n=20 participants at risk
QW SC injection for 16 weeks
|
Main Study Placebo
n=21 participants at risk
QW SC injection for 16 weeks
|
Cohort C EFX 50 mg
n=20 participants at risk
QW SC injection for 16 weeks
|
Cohort C Placebo
n=10 participants at risk
QW SC injection for 16 weeks
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site pruritus
|
10.5%
2/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
10.0%
2/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
26.3%
5/19 • 20-24 weeks
|
57.9%
11/19 • 20-24 weeks
|
35.0%
7/20 • 20-24 weeks
|
19.0%
4/21 • 20-24 weeks
|
50.0%
10/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Nausea
|
42.1%
8/19 • 20-24 weeks
|
26.3%
5/19 • 20-24 weeks
|
60.0%
12/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
45.0%
9/20 • 20-24 weeks
|
20.0%
2/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
31.6%
6/19 • 20-24 weeks
|
21.1%
4/19 • 20-24 weeks
|
25.0%
5/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
20.0%
4/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.3%
1/19 • 20-24 weeks
|
15.8%
3/19 • 20-24 weeks
|
20.0%
4/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Frequent bowel movement
|
15.8%
3/19 • 20-24 weeks
|
10.5%
2/19 • 20-24 weeks
|
20.0%
4/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.8%
3/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
15.0%
3/20 • 20-24 weeks
|
20.0%
2/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • 20-24 weeks
|
15.8%
3/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
20.0%
4/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/19 • 20-24 weeks
|
10.5%
2/19 • 20-24 weeks
|
10.0%
2/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/19 • 20-24 weeks
|
10.5%
2/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
10.0%
2/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Feces soft
|
5.3%
1/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
10.0%
2/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/19 • 20-24 weeks
|
10.5%
2/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
20.0%
2/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Toothache
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Abdominal tenderness
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Defecation Urgency
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Eosinophilic esophagitis
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Odynophagia
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
10.0%
2/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
General disorders
Fatigue
|
5.3%
1/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
35.0%
7/20 • 20-24 weeks
|
19.0%
4/21 • 20-24 weeks
|
10.0%
2/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
General disorders
Injection site erythema
|
10.5%
2/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
25.0%
5/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
25.0%
5/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
General disorders
Injection site reaction
|
10.5%
2/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
20.0%
4/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
30.0%
6/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
General disorders
Injection site bruising
|
10.5%
2/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
20.0%
4/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
General disorders
Asthenia
|
10.5%
2/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
General disorders
Chills
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
10.0%
2/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
General disorders
Injection site irritation
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
General disorders
Injection site pain
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
9.5%
2/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
General disorders
Thirst
|
5.3%
1/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
General disorders
Axillary pain
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
General disorders
Early satiety
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
General disorders
Injection site hemorrhage
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
General disorders
Injection site rash
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
General disorders
Chest pain
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
General disorders
Edema
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
26.3%
5/19 • 20-24 weeks
|
10.5%
2/19 • 20-24 weeks
|
15.0%
3/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
10.5%
2/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
15.0%
3/20 • 20-24 weeks
|
9.5%
2/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Bronchitis
|
15.8%
3/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Sinusitis
|
10.5%
2/19 • 20-24 weeks
|
10.5%
2/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
20.0%
4/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Urinary tract infection
|
10.5%
2/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Cellulitis
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Ear infection
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Injection site cellulitis
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Viral pharyngitis
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Folliculitis
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Infections and infestations
Esophageal candidiasis
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Otitis externa
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Metabolism and nutrition disorders
Increased appetite
|
21.1%
4/19 • 20-24 weeks
|
26.3%
5/19 • 20-24 weeks
|
25.0%
5/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
15.0%
3/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • 20-24 weeks
|
10.5%
2/19 • 20-24 weeks
|
15.0%
3/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
10.0%
2/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Metabolism and nutrition disorders
Lack of satiety
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Metabolism and nutrition disorders
Food aversion
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Metabolism and nutrition disorders
Vitamin B complex deficiency
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
10.0%
2/20 • 20-24 weeks
|
9.5%
2/21 • 20-24 weeks
|
15.0%
3/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.3%
1/19 • 20-24 weeks
|
10.5%
2/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
1/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
10.0%
2/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin odor abnormal
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/19 • 20-24 weeks
|
10.5%
2/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
9.5%
2/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19 • 20-24 weeks
|
10.5%
2/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
9.5%
2/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
10.0%
2/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
10.0%
2/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
15.0%
3/20 • 20-24 weeks
|
14.3%
3/21 • 20-24 weeks
|
20.0%
4/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
10.0%
2/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Nervous system disorders
Dysgeusia
|
5.3%
1/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Nervous system disorders
Tremor
|
5.3%
1/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Nervous system disorders
Ageusia
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Nervous system disorders
Akathisia
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Nervous system disorders
Somnolence
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Nervous system disorders
Tension headache
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Nervous system disorders
Anosmia
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Nervous system disorders
Hemorrhage intracranial
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
10.0%
2/20 • 20-24 weeks
|
9.5%
2/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
1/19 • 20-24 weeks
|
10.5%
2/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.3%
1/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
10.0%
2/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hyperactive pharyngeal reflex
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/19 • 20-24 weeks
|
10.5%
2/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Investigations
Weight increased
|
5.3%
1/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Investigations
C-reactive protein increased
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Investigations
Hepatic enzyme increased
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Investigations
Blood glucose increased
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Investigations
Lipase increased
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Investigations
Occult blood positive
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Investigations
Blood glucose decreased
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Investigations
Total lung capacity decreased
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19 • 20-24 weeks
|
10.5%
2/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
10.0%
2/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Injury, poisoning and procedural complications
Burns first degree
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Psychiatric disorders
Insomnia
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Psychiatric disorders
Irritability
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Psychiatric disorders
Libido decreased
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Psychiatric disorders
Mood altered
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Psychiatric disorders
Panic attack
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Psychiatric disorders
Stress
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/19 • 20-24 weeks
|
15.8%
3/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
4.8%
1/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/19 • 20-24 weeks
|
5.3%
1/19 • 20-24 weeks
|
15.0%
3/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Reproductive system and breast disorders
Retracted nipples
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Immune system disorders
Seasonal allergy
|
5.3%
1/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
10.0%
1/10 • 20-24 weeks
|
|
Eye disorders
Eyelid edema
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/19 • 20-24 weeks
|
0.00%
0/20 • 20-24 weeks
|
0.00%
0/21 • 20-24 weeks
|
5.0%
1/20 • 20-24 weeks
|
0.00%
0/10 • 20-24 weeks
|
Additional Information
Brittany de Temple, Senior Director Clinical Operations
Akero Therapeutics, Inc.
Phone: (650) 868-7935
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place