Trial Outcomes & Findings for A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities (NCT NCT06023095)
NCT ID: NCT06023095
Last Updated: 2026-07-17
Results Overview
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Baseline through Week 18 (Cohort 1) & Week 26 (Cohort 2)
Results posted on
2026-07-17
Participant Flow
Participant milestones
| Measure |
LY3502970 (Cohort 1)
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg and then 12 mg LY3502970 administered orally once daily (QD) from Day 1 for 16 weeks.
|
LY3502970 (Cohort 2)
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD from Day 1 for 24 weeks.
|
Placebo
Participants received placebo administered orally QD.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
4
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
10
|
10
|
4
|
|
Overall Study
COMPLETED
|
9
|
9
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
LY3502970 (Cohort 1)
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg and then 12 mg LY3502970 administered orally once daily (QD) from Day 1 for 16 weeks.
|
LY3502970 (Cohort 2)
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD from Day 1 for 24 weeks.
|
Placebo
Participants received placebo administered orally QD.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities
Baseline characteristics by cohort
| Measure |
LY3502970 (Cohort 1)
n=10 Participants
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg and then 12 mg LY3502970 administered QD from Day 1 for 16 weeks.
|
LY3502970 (Cohort 2)
n=10 Participants
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD from Day 1 for 24 weeks.
|
Placebo
n=4 Participants
Participants received placebo administered orally QD.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.8 years
STANDARD_DEVIATION 5.2 • n=20 Participants
|
29.8 years
STANDARD_DEVIATION 7.6 • n=20 Participants
|
31.5 years
STANDARD_DEVIATION 11.0 • n=40 Participants
|
30.1 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 18 (Cohort 1) & Week 26 (Cohort 2)Population: All enrolled participants who receive at least 1 dose of study drug.
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Outcome measures
| Measure |
LY3502970 (Cohort 1)
n=10 Participants
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg and then 12 mg LY3502970 administered orally QD from Day 1 for 16 weeks.
|
LY3502970 (Cohort 2)
n=10 Participants
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD from Day 1 for 24 weeks.
|
Placebo
n=4 Participants
Participants received placebo administered orally QD.
|
Placebo (Cohort 2)
Participants received placebo for 24 weeks.
|
|---|---|---|---|---|
|
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
TEAEs
|
10 Participants
|
8 Participants
|
3 Participants
|
—
|
|
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 56 and Day 112 (Predose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post dose)Population: All enrolled participants who received at least 1 dose of study drug and had evaluable PK data for this outcome were included in the analysis; the number of participants analyzed varies by timepoint based on data availability.
Pharmacokinetic parameter Cmax (maximum observed plasma concentration) of LY3502970 following multiple oral doses at escalating dose levels. Cmax was assessed at steady state using plasma concentration-time data collected at specified timepoints per protocol.
Outcome measures
| Measure |
LY3502970 (Cohort 1)
n=10 Participants
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg and then 12 mg LY3502970 administered orally QD from Day 1 for 16 weeks.
|
LY3502970 (Cohort 2)
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD from Day 1 for 24 weeks.
|
Placebo
Participants received placebo administered orally QD.
|
Placebo (Cohort 2)
Participants received placebo for 24 weeks.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 at Steady State (Cohort 1)
Day 56
|
17.6 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 39
|
—
|
—
|
—
|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 at Steady State (Cohort 1)
Day 112
|
61.3 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 43
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28, Day 84, Day 140, and Day 168 (Predose, 0.5, 1, 2, 4, 6, 12, and 24 hours post dose)Population: All enrolled participants who received at least 1 dose of study drug and had evaluable PK data for this outcome were included in the analysis; the number of participants analyzed varies by timepoint based on data availability.
Pharmacokinetic parameter Cmax (maximum observed plasma concentration) of LY3502970 following multiple oral doses at escalating dose levels. Cmax was assessed at steady state using plasma concentration-time data collected at specified timepoints per protocol.
Outcome measures
| Measure |
LY3502970 (Cohort 1)
n=10 Participants
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg and then 12 mg LY3502970 administered orally QD from Day 1 for 16 weeks.
|
LY3502970 (Cohort 2)
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD from Day 1 for 24 weeks.
|
Placebo
Participants received placebo administered orally QD.
|
Placebo (Cohort 2)
Participants received placebo for 24 weeks.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 at Steady State (Cohort 2)
Day 28
|
5.01 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 44
|
—
|
—
|
—
|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 at Steady State (Cohort 2)
Day 84
|
35.1 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 41
|
—
|
—
|
—
|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 at Steady State (Cohort 2)
Day 140
|
116 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 42
|
—
|
—
|
—
|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 at Steady State (Cohort 2)
Day 168
|
159 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 41
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: Day 56 and Day 112 (Predose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post dose)Population: All enrolled participants who received at least 1 dose of study drug and had evaluable PK data for this outcome were included in the analysis; the number of participants analyzed varies by timepoint based on data availability.
Pharmacokinetic parameter AUC0-24 of LY3502970 following multiple oral doses at escalating dose levels. AUC0-24 was derived using plasma concentration-time data collected at predefined time points over a 24-hour dosing interval at steady state per protocol.
Outcome measures
| Measure |
LY3502970 (Cohort 1)
n=10 Participants
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg and then 12 mg LY3502970 administered orally QD from Day 1 for 16 weeks.
|
LY3502970 (Cohort 2)
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD from Day 1 for 24 weeks.
|
Placebo
Participants received placebo administered orally QD.
|
Placebo (Cohort 2)
Participants received placebo for 24 weeks.
|
|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hour Time Point (AUC0-24) of LY3502970 at Steady State (Cohort 1)
Day 56
|
266 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
|
PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hour Time Point (AUC0-24) of LY3502970 at Steady State (Cohort 1)
Day 112
|
1010 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28, Day 84, Day 140, and Day 168 (Predose, 0.5, 1, 2, 4, 6, 12, and 24 hours post dose)Population: All enrolled participants who receive at least 1 dose of study drug and had evaluable PK data for this outcome were included in the analysis; the number of participants analyzed varies by timepoint based on data availability.
Pharmacokinetic parameter AUC0-24 of LY3502970 following multiple oral doses at escalating dose levels. AUC0-24 was derived using plasma concentration-time data collected at predefined time points over a 24-hour dosing interval at steady state per protocol.
Outcome measures
| Measure |
LY3502970 (Cohort 1)
n=10 Participants
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg and then 12 mg LY3502970 administered orally QD from Day 1 for 16 weeks.
|
LY3502970 (Cohort 2)
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD from Day 1 for 24 weeks.
|
Placebo
Participants received placebo administered orally QD.
|
Placebo (Cohort 2)
Participants received placebo for 24 weeks.
|
|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hour Time Point (AUC0-24) of LY3502970 at Steady State (Cohort 2)
Day 28
|
80.4 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 42
|
—
|
—
|
—
|
|
PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hour Time Point (AUC0-24) of LY3502970 at Steady State (Cohort 2)
Day 84
|
520 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 37
|
—
|
—
|
—
|
|
PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hour Time Point (AUC0-24) of LY3502970 at Steady State (Cohort 2)
Day 140
|
1650 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
|
PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hour Time Point (AUC0-24) of LY3502970 at Steady State (Cohort 2)
Day 168
|
2620 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 40
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)Population: All enrolled participants who receive at least 1 dose of study drug and had evaluable PD data for this outcome.
PD: Change from baseline in Body Mass Index calculated as post-baseline value minus baseline value. Negative values indicate a decrease in Body Mass Index.
Outcome measures
| Measure |
LY3502970 (Cohort 1)
n=9 Participants
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg and then 12 mg LY3502970 administered orally QD from Day 1 for 16 weeks.
|
LY3502970 (Cohort 2)
n=9 Participants
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD from Day 1 for 24 weeks.
|
Placebo
n=2 Participants
Participants received placebo administered orally QD.
|
Placebo (Cohort 2)
n=1 Participants
Participants received placebo for 24 weeks.
|
|---|---|---|---|---|
|
PD: Change From Baseline in Body Mass Index
|
-2.3046 kilograms per square meter (kg/m²)
Standard Deviation 1.1819
|
-3.5964 kilograms per square meter (kg/m²)
Standard Deviation 1.4441
|
NA kilograms per square meter (kg/m²)
Standard Deviation NA
Summary statistics were not calculated due to the small sample size (n=2); therefore, individual participant data are reported.
The individual change-from-baseline values are --1.134 kg/m² (minimum) and 0.258 kg/m² (maximum).
|
NA kilograms per square meter (kg/m²)
Standard Deviation NA
Summary statistics were not calculated because only one participant (n=1) was included; therefore, individual participant data are reported.
The individual change-from-baseline value is -1.394 kg/m²
|
SECONDARY outcome
Timeframe: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)Population: All enrolled participants who receive at least 1 dose of study drug and had evaluable PD data for this outcome.
PD: Change from baseline in body weight calculated as post-baseline value minus baseline value. Negative values indicate a decrease in body weight.
Outcome measures
| Measure |
LY3502970 (Cohort 1)
n=9 Participants
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg and then 12 mg LY3502970 administered orally QD from Day 1 for 16 weeks.
|
LY3502970 (Cohort 2)
n=9 Participants
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD from Day 1 for 24 weeks.
|
Placebo
n=2 Participants
Participants received placebo administered orally QD.
|
Placebo (Cohort 2)
n=1 Participants
Participants received placebo for 24 weeks.
|
|---|---|---|---|---|
|
Pharmacodynamics (PD): Change From Baseline in Body Weight
|
-6.156 kilograms (kg)
Standard Deviation 3.710
|
-10.211 kilograms (kg)
Standard Deviation 4.011
|
NA kilograms (kg)
Standard Deviation NA
Summary statistics were not calculated due to the small sample size (n=2); therefore, individual participant data are reported.
The individual change-from-baseline values are --3.05 kg (minimum) and 0.80 kg (maximum).
|
NA kilograms (kg)
Standard Deviation NA
Summary statistics were not calculated because only one participant (n=1) was included; therefore, individual participant data are reported.
The individual change-from-baseline value is 3.75 kg.
|
SECONDARY outcome
Timeframe: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)Population: All enrolled participants who receive at least 1 dose of study drug and had evaluable PD data for this outcome.
PD: Change from baseline in Waist Circumference calculated as post-baseline value minus baseline value. Negative values indicate a decrease in Waist Circumference.
Outcome measures
| Measure |
LY3502970 (Cohort 1)
n=9 Participants
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg and then 12 mg LY3502970 administered orally QD from Day 1 for 16 weeks.
|
LY3502970 (Cohort 2)
n=9 Participants
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD from Day 1 for 24 weeks.
|
Placebo
n=2 Participants
Participants received placebo administered orally QD.
|
Placebo (Cohort 2)
n=1 Participants
Participants received placebo for 24 weeks.
|
|---|---|---|---|---|
|
PD: Change From Baseline in Waist Circumference
|
-5.778 centimeters (cm)
Standard Deviation 2.879
|
-11.667 centimeters (cm)
Standard Deviation 3.466
|
NA centimeters (cm)
Standard Deviation NA
Summary statistics were not calculated due to the small sample size (n=2); therefore, individual participant data are reported.
The individual change-from-baseline values are -4.50 cm (minimum) and 0.25 cm (maximum).
|
NA centimeters (cm)
Standard Deviation NA
Summary statistics were not calculated because only one participant (n=1) was included; therefore, individual participant data are reported.
The individual change-from-baseline value is -5.00 cm.
|
SECONDARY outcome
Timeframe: Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)Population: All enrolled participants who receive at least 1 dose of study drug and had evaluable PD data for this outcome.
PD: Change From Baseline in Fasting Plasma Glucose calculated as post-baseline value minus baseline value. Negative values indicate a decrease from baseline
Outcome measures
| Measure |
LY3502970 (Cohort 1)
n=9 Participants
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg and then 12 mg LY3502970 administered orally QD from Day 1 for 16 weeks.
|
LY3502970 (Cohort 2)
n=9 Participants
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD from Day 1 for 24 weeks.
|
Placebo
n=2 Participants
Participants received placebo administered orally QD.
|
Placebo (Cohort 2)
n=1 Participants
Participants received placebo for 24 weeks.
|
|---|---|---|---|---|
|
PD: Change From Baseline in Fasting Plasma Glucose
|
-0.50 millimoles per liter (mmol/L)
Standard Deviation 0.45
|
-0.17 millimoles per liter (mmol/L)
Standard Deviation 0.28
|
NA millimoles per liter (mmol/L)
Standard Deviation NA
Summary statistics were not calculated due to the small sample size (n=2); therefore, individual participant data are reported.
The individual change-from-baseline values are -0.2 mmol/L (minimum) and 0 mmol/L (maximum).
|
NA millimoles per liter (mmol/L)
Standard Deviation NA
Summary statistics were not calculated because only one participant (n=1) was included; therefore, individual participant data are reported.
The individual change-from-baseline value is 0.1 mmol/L.
|
Adverse Events
LY3502970 (Cohort 1)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
LY3502970 (Cohort 2)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY3502970 (Cohort 1)
n=10 participants at risk
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg and then 12 mg LY3502970 administered orally QD from Day 1 for 16 weeks.
|
LY3502970 (Cohort 2)
n=10 participants at risk
Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD from Day 1 for 24 weeks.
|
Placebo
n=4 participants at risk
Participants received placebo administered orally QD.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
20.0%
2/10 • Number of events 3 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
25.0%
1/4 • Number of events 3 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Cardiac disorders
Atrioventricular block first degree
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Eye disorders
Dry eye
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Eye disorders
Ocular hyperaemia
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
20.0%
2/10 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
20.0%
2/10 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
25.0%
1/4 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Abdominal distension
|
30.0%
3/10 • Number of events 4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
50.0%
5/10 • Number of events 14 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Abdominal pain
|
30.0%
3/10 • Number of events 6 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
30.0%
3/10 • Number of events 5 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
2/10 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
20.0%
2/10 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 3 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
60.0%
6/10 • Number of events 16 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
70.0%
7/10 • Number of events 16 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
25.0%
1/4 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Enteritis
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Eructation
|
40.0%
4/10 • Number of events 4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
20.0%
2/10 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
20.0%
2/10 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
2/10 • Number of events 3 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
50.0%
5/10 • Number of events 10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
25.0%
1/4 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
30.0%
3/10 • Number of events 4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • Number of events 7 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
80.0%
8/10 • Number of events 11 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Regurgitation
|
10.0%
1/10 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
10.0%
1/10 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
4/10 • Number of events 15 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
50.0%
5/10 • Number of events 5 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
General disorders
Chest pain
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Infections and infestations
Herpes zoster
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Infections and infestations
Pharyngitis
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Infections and infestations
Upper respiratory tract infection
|
40.0%
4/10 • Number of events 6 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
60.0%
6/10 • Number of events 8 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
50.0%
2/4 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Investigations
Electrocardiogram q wave abnormal
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Investigations
Electrocardiogram st segment abnormal
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Investigations
Electrocardiogram t wave abnormal
|
20.0%
2/10 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
20.0%
2/10 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Investigations
Electrocardiogram t wave alternans
|
10.0%
1/10 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Investigations
Granulocyte count increased
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Investigations
Lipase increased
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
20.0%
2/10 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Investigations
Lymphocyte count increased
|
20.0%
2/10 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Investigations
Monocyte count increased
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
25.0%
1/4 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
25.0%
1/4 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Investigations
Protein urine present
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
30.0%
3/10 • Number of events 4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
50.0%
2/4 • Number of events 3 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Investigations
Urobilinogen urine increased
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Investigations
White blood cell count increased
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
70.0%
7/10 • Number of events 8 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
70.0%
7/10 • Number of events 12 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
50.0%
2/4 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
30.0%
3/10 • Number of events 5 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
30.0%
3/10 • Number of events 3 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Nervous system disorders
Somnolence
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Psychiatric disorders
Initial insomnia
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Psychiatric disorders
Terminal insomnia
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Renal and urinary disorders
Proteinuria
|
20.0%
2/10 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
25.0%
1/4 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
20.0%
2/10 • Number of events 2 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
25.0%
1/4 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/10 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
0.00%
0/4 • Baseline up to 182 Days
All enrolled participants who receive at least 1 dose of study drug or placebo. Participants were analyzed according to the intervention they actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60