Trial Outcomes & Findings for A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic Fibrosis (NCT NCT03119649)
NCT ID: NCT03119649
Last Updated: 2018-11-16
Results Overview
Number of participants with any treatment-emergent adverse events (TEAEs) and serious or treatment-related TEAEs, as well as number of patients with TEAEs by worst intensity reported (mild, moderate, or severe).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
First administration (Day 1) through Follow-up (Day 43)
Results posted on
2018-11-16
Participant Flow
Participant milestones
| Measure |
Pooled Placebo
Participants received three matching placebo tablets orally, once a day (QD) for 29 days.
|
Cohort A: GLPG2222 50 mg QD
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
Cohort A: GLPG2222 100 mg QD
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
Cohort B: GLPG2222 200 mg QD
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
|
Cohort B: GLPG2222 400 mg QD
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet, orally, QD for 29 days.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
10
|
14
|
14
|
|
Overall Study
COMPLETED
|
11
|
10
|
10
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Pooled Placebo
n=11 Participants
Participants received three matching placebo tablets orally, QD for 29 days.
|
Cohort A: GLPG2222 50 mg QD
n=10 Participants
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
Cohort A: GLPG2222 100 mg QD
n=10 Participants
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
Cohort B: GLPG2222 200 mg QD
n=14 Participants
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
|
Cohort B: GLPG2222 400 mg QD
n=14 Participants
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
27.0 years
n=93 Participants
|
26.0 years
n=4 Participants
|
24.0 years
n=27 Participants
|
32.0 years
n=483 Participants
|
26.0 years
n=36 Participants
|
27.0 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
25 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
34 Participants
n=10 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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
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
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
56 Participants
n=10 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: First administration (Day 1) through Follow-up (Day 43)Population: Safety population
Number of participants with any treatment-emergent adverse events (TEAEs) and serious or treatment-related TEAEs, as well as number of patients with TEAEs by worst intensity reported (mild, moderate, or severe).
Outcome measures
| Measure |
Cohort A: GLPG2222 100 mg QD
n=10 Participants
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
Cohort B: GLPG2222 200 mg QD
n=14 Participants
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
|
Cohort B: GLPG2222 400 mg QD
n=14 Participants
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
|
Pooled Placebo
n=11 Participants
Participants received three matching placebo tablets orally, QD for 29 days.
|
Cohort A: GLPG2222 50 mg QD
n=10 Participants
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
Any Treatment-related TEAE
|
6 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Any TEAE
|
10 Participants
|
11 Participants
|
9 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Any Serious TEAE
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Worst TEAE Intensity=Mild
|
7 Participants
|
8 Participants
|
9 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Worst TEAE Intensity=Moderate
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Worst TEAE Intensity=Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Prior to dosing on Days 1 and 29, or at early discontinuationPopulation: Intent-to-treat (ITT) population: all enrolled participants who received at least one dose of study drug and had at least one post-baseline assessment with efficacy data. Only participants with non-missing data at baseline were included in the analysis; 3 participants had missing sweat chloride concentration data at baseline.
Two sweat collections, one from each arm, were obtained. Mean sweat chloride concentration was determined from both arms and measured as millimoles per liter (mmol/L). Baseline was defined as the predose value on Day 1 (or the last non-missing predose measurement).
Outcome measures
| Measure |
Cohort A: GLPG2222 100 mg QD
n=8 Participants
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
Cohort B: GLPG2222 200 mg QD
n=14 Participants
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
|
Cohort B: GLPG2222 400 mg QD
n=14 Participants
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
|
Pooled Placebo
n=11 Participants
Participants received three matching placebo tablets orally, QD for 29 days.
|
Cohort A: GLPG2222 50 mg QD
n=9 Participants
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Sweat Chloride Concentration at Day 29
|
-6.6 mmol/L
Standard Error 3.29
|
-18.3 mmol/L
Standard Error 2.49
|
-8.8 mmol/L
Standard Error 2.49
|
-2.5 mmol/L
Standard Error 2.79
|
-5.8 mmol/L
Standard Error 3.08
|
SECONDARY outcome
Timeframe: Predose and between 1 and 2 hours postdose on Days 1 and 29, or at early discontinuationPopulation: ITT Population
Percent predicted FEV1 for age, gender, and height was determined from standardized spirometry assessments and estimated using the 2012 Global Lungs Initiative equation. Baseline was defined as the last non-missing predose assessment on Day 1.
Outcome measures
| Measure |
Cohort A: GLPG2222 100 mg QD
n=10 Participants
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
Cohort B: GLPG2222 200 mg QD
n=14 Participants
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
|
Cohort B: GLPG2222 400 mg QD
n=14 Participants
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
|
Pooled Placebo
n=11 Participants
Participants received three matching placebo tablets orally, QD for 29 days.
|
Cohort A: GLPG2222 50 mg QD
n=10 Participants
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Percent (%) Predicted FEV1 (%FEV1) at Day 29
|
-0.3 % predicted FEV1
Standard Error 1.51
|
0.0 % predicted FEV1
Standard Error 1.27
|
1.3 % predicted FEV1
Standard Error 1.26
|
-1.0 % predicted FEV1
Standard Error 1.45
|
0.1 % predicted FEV1
Standard Error 1.50
|
SECONDARY outcome
Timeframe: Prior to dosing on Days 1 and 29, or at early discontinuationPopulation: ITT Population
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. The respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), derived from Questions 40, 41, 42, 45, and 46 if at least 50% of the questions had non-missing data. The scale score ranged from 0-100; higher scores indicated fewer symptoms and better health-related quality of life with a negative change indicating a worsening of symptoms. A change of 4 is considered clinically relevant.
Outcome measures
| Measure |
Cohort A: GLPG2222 100 mg QD
n=10 Participants
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
Cohort B: GLPG2222 200 mg QD
n=14 Participants
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
|
Cohort B: GLPG2222 400 mg QD
n=14 Participants
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
|
Pooled Placebo
n=11 Participants
Participants received three matching placebo tablets orally, QD for 29 days.
|
Cohort A: GLPG2222 50 mg QD
n=10 Participants
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in the Respiratory Domain of the Cystic Fibrosis Questionnaire-Revised (CFQ-R) at Day 29
|
-0.7 units on a scale
Standard Error 3.48
|
4.5 units on a scale
Standard Error 2.93
|
-0.8 units on a scale
Standard Error 2.93
|
-2.4 units on a scale
Standard Error 3.32
|
0.4 units on a scale
Standard Error 3.47
|
SECONDARY outcome
Timeframe: Day 15 (predose and 0.5, 1, 2, 3, 4, 6, and 8 hours postdose) and prior to dosing on Day 29Population: Pharmacokinetic (PK) Population: all participants who were exposed to GLPG2222 and who had available and evaluable PK data (excluding all protocol violations/deviations or adverse events that may have had an impact on the PK analysis). Data were not calculable for 1 patient.
Maximum concentration of GLPG2222 after multiple dosing (ng/ML), obtained directly from the observed concentration versus time data. All pharmacokinetic (PK) parameters were determined from Day 15; Day 29 data were determined if the participant was not available for full PK profiling on Day 15.
Outcome measures
| Measure |
Cohort A: GLPG2222 100 mg QD
n=14 Participants
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
Cohort B: GLPG2222 200 mg QD
n=13 Participants
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
|
Cohort B: GLPG2222 400 mg QD
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
|
Pooled Placebo
n=10 Participants
Participants received three matching placebo tablets orally, QD for 29 days.
|
Cohort A: GLPG2222 50 mg QD
n=10 Participants
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
|---|---|---|---|---|---|
|
Mean Maximum Observed Plasma Concentration (Cmax; Nanograms Per Milliliter [mg/mL]) of GLPG2222
|
2490 ng/mL
Standard Deviation 535
|
5330 ng/mL
Standard Deviation 2700
|
—
|
478 ng/mL
Standard Deviation 128
|
1170 ng/mL
Standard Deviation 395
|
SECONDARY outcome
Timeframe: Days 15 and 29 (predose)Population: PK Population
Plasma concentration of GLPG2222 observed at pre-dose (ng/mL), obtained directly from the observed concentration versus time data. Ctrough was calculated using both Day 15 and Day 29 PK data.
Outcome measures
| Measure |
Cohort A: GLPG2222 100 mg QD
n=14 Participants
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
Cohort B: GLPG2222 200 mg QD
n=14 Participants
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
|
Cohort B: GLPG2222 400 mg QD
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
|
Pooled Placebo
n=10 Participants
Participants received three matching placebo tablets orally, QD for 29 days.
|
Cohort A: GLPG2222 50 mg QD
n=10 Participants
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
|---|---|---|---|---|---|
|
Mean GLPG2222 Plasma Concentration Observed at Predose (Ctrough; ng/mL)
|
343 ng/mL
Standard Deviation 204
|
677 ng/mL
Standard Deviation 659
|
—
|
48.1 ng/mL
Standard Deviation 33.7
|
132 ng/mL
Standard Deviation 87.2
|
SECONDARY outcome
Timeframe: Day 15 (predose and 0.5, 1, 2, 3, 4, 6, and 8 hours postdose) and prior to dosing on Day 29Population: PK Population; data were not calculable for 1 patient.
Time of occurrence of maximum concentration of GLPG2222 after multiple dosing (h), obtained directly from the observed concentration versus time data. All PK parameters were determined from Day 15; Day 29 data were determined if the participant was not available for full PK profiling on Day 15.
Outcome measures
| Measure |
Cohort A: GLPG2222 100 mg QD
n=14 Participants
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
Cohort B: GLPG2222 200 mg QD
n=13 Participants
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
|
Cohort B: GLPG2222 400 mg QD
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
|
Pooled Placebo
n=10 Participants
Participants received three matching placebo tablets orally, QD for 29 days.
|
Cohort A: GLPG2222 50 mg QD
n=10 Participants
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
|---|---|---|---|---|---|
|
Median Time to Occurrence of GLPG2222 Cmax (Tmax; Hours [h])
|
3.0 hours
Interval 2.0 to 4.0
|
2.0 hours
Interval 0.5 to 6.0
|
—
|
2.0 hours
Interval 1.0 to 6.0
|
2.0 hours
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: Day 15 (predose and 0.5, 1, 2, 3, 4, 6, and 8 hours postdose) and prior to dosing on Day 29Population: PK Population; data were not calculable for 1 patient.
Area under the concentration-time curve from time 0 up to 24 hours following multiple dosing (ng.h/mL), calculated by linear up/log down trapezoidal summation. All PK parameters were determined from Day 15; Day 29 data were determined if the participant was not available for full PK profiling on Day 15.
Outcome measures
| Measure |
Cohort A: GLPG2222 100 mg QD
n=14 Participants
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
Cohort B: GLPG2222 200 mg QD
n=13 Participants
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
|
Cohort B: GLPG2222 400 mg QD
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
|
Pooled Placebo
n=10 Participants
Participants received three matching placebo tablets orally, QD for 29 days.
|
Cohort A: GLPG2222 50 mg QD
n=10 Participants
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
|---|---|---|---|---|---|
|
Mean Area Under the Concentration-Time Curve From Time 0 up to 24 Hours Following Multiple Dosing (AUC[0-t]; ng.h/mL) of GLPG2222
|
22900 ng.h/mL
Standard Deviation 7530
|
46400 ng.h/mL
Standard Deviation 25500
|
—
|
3850 ng.h/mL
Standard Deviation 1670
|
9670 ng.h/mL
Standard Deviation 3770
|
Adverse Events
Pooled Placebo
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort A: GLPG2222 50 mg QD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort A: GLPG2222 100 mg QD
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort B: GLPG2222 200 mg QD
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort B: GLPG2222 400 mg QD
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pooled Placebo
n=11 participants at risk
Participants received three matching placebo tablets orally, QD for 29 days.
|
Cohort A: GLPG2222 50 mg QD
n=10 participants at risk
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
Cohort A: GLPG2222 100 mg QD
n=10 participants at risk
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
Cohort B: GLPG2222 200 mg QD
n=14 participants at risk
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
|
Cohort B: GLPG2222 400 mg QD
n=14 participants at risk
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
|
|---|---|---|---|---|---|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
18.2%
2/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
Other adverse events
| Measure |
Pooled Placebo
n=11 participants at risk
Participants received three matching placebo tablets orally, QD for 29 days.
|
Cohort A: GLPG2222 50 mg QD
n=10 participants at risk
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
Cohort A: GLPG2222 100 mg QD
n=10 participants at risk
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
|
Cohort B: GLPG2222 200 mg QD
n=14 participants at risk
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
|
Cohort B: GLPG2222 400 mg QD
n=14 participants at risk
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
3/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
50.0%
5/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
21.4%
3/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
28.6%
4/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
50.0%
5/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
20.0%
2/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Respiratory, thoracic and mediastinal disorders
Decreased bronchial secretion
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depth decreased
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Respiratory, thoracic and mediastinal disorders
Sputum decreased
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
20.0%
2/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
14.3%
2/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
14.3%
2/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
21.4%
3/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Infections and infestations
Ear infection
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Infections and infestations
Pharyngitis
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Infections and infestations
Purulent discharge
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Infections and infestations
Skin candida
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
30.0%
3/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
14.3%
2/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
20.0%
2/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
30.0%
3/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
30.0%
3/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
35.7%
5/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
21.4%
3/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Nervous system disorders
Loss of consciousness
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Nervous system disorders
Retrograde amnesia
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
General disorders
Fatigue
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
20.0%
2/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
14.3%
2/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
General disorders
Pyrexia
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
14.3%
2/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
General disorders
Adverse drug reaction
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
General disorders
Asthenia
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
General disorders
Chest discomfort
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
General disorders
Catheter site related reaction
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
General disorders
Exercise tolerance increased
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
General disorders
Pain
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Investigations
Blood glucose decreased
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Investigations
Blood uric acid increased
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Investigations
Body temperature increased
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Investigations
Neutrophil count increased
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Investigations
Platelet count increased
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Investigations
Red blood cells urine positive
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Investigations
Thrombin time prolonged
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Investigations
Urine leukocyte esterase positive
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Investigations
Weight decreased
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Investigations
White blood cell count increased
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Investigations
White blood cells urine positive
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Eye disorders
Blepharospasm
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Eye disorders
Eye pruritus
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Reproductive system and breast disorders
Azoospermia
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Reproductive system and breast disorders
Menstruation irregular
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
20.0%
2/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
10.0%
1/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Injury, poisoning and procedural complications
Wound
|
9.1%
1/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
|
Vascular disorders
Hot flush
|
0.00%
0/11 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/10 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
0.00%
0/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
7.1%
1/14 • From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator must agree that before publishing or communicating any results of the trial, the sponsor has at least 90 days for full review of the information prior to submission.
- Publication restrictions are in place
Restriction type: OTHER