Trial Outcomes & Findings for SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Inhalation (NCT NCT04631705)
NCT ID: NCT04631705
Last Updated: 2024-10-03
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Over first 7 days after study drug administration
Results posted on
2024-10-03
Participant Flow
Participant milestones
| Measure |
1A: Healthy, 50 mg Inh.
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1B: Healthy, 100 mg Inh.
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1C: Healthy, 250 mg Inh.
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
2A: Infected, 50 mg Inh.
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2B: Infected, 100 mg Inh.
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2C: Infected, 250 mg Inh.
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2D: Infected, Placebo Inh., Placebo i.v.
Double blind and randomized, SARS-CoV-2-infected, placebo by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., Placebo i.v.
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., 40 mg/kg i.v.
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, DZIF-10c by i.v. infusion
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
10
|
8
|
9
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
9
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
1A: Healthy, 50 mg Inh.
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1B: Healthy, 100 mg Inh.
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1C: Healthy, 250 mg Inh.
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
2A: Infected, 50 mg Inh.
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2B: Infected, 100 mg Inh.
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2C: Infected, 250 mg Inh.
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2D: Infected, Placebo Inh., Placebo i.v.
Double blind and randomized, SARS-CoV-2-infected, placebo by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., Placebo i.v.
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., 40 mg/kg i.v.
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, DZIF-10c by i.v. infusion
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
1A: Healthy, 50 mg Inh.
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1B: Healthy, 100 mg Inh.
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1C: Healthy, 250 mg Inh.
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
2A: Infected, 50 mg Inh.
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2B: Infected, 100 mg Inh.
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2C: Infected, 250 mg Inh.
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2D: Infected, Placebo Inh., Placebo i.v.
n=10 Participants
Double blind and randomized, SARS-CoV-2-infected, placebo by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., Placebo i.v.
n=8 Participants
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., 40 mg/kg i.v.
n=9 Participants
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, DZIF-10c by i.v. infusion
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
43 years
n=3 Participants
|
33 years
n=3 Participants
|
27 years
n=3 Participants
|
35 years
n=3 Participants
|
39 years
n=3 Participants
|
41 years
n=3 Participants
|
34 years
n=10 Participants
|
32 years
n=8 Participants
|
28 years
n=9 Participants
|
33 years
n=45 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=9 Participants
|
15 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
8 Participants
n=10 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=9 Participants
|
30 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Germany
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
10 participants
n=10 Participants
|
8 participants
n=8 Participants
|
9 participants
n=9 Participants
|
45 participants
n=45 Participants
|
PRIMARY outcome
Timeframe: Over first 7 days after study drug administrationOutcome measures
| Measure |
1A: Healthy, 50 mg Inh.
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1B: Healthy, 100 mg Inh.
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1C: Healthy, 250 mg Inh.
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
2A: Infected, 50 mg Inh.
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2B: Infected, 100 mg Inh.
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2C: Infected, 250 mg Inh.
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2D: Infected, Placebo Inh., Placebo i.v.
n=10 Participants
Double blind and randomized, SARS-CoV-2-infected, placebo by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., Placebo i.v.
n=8 Participants
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., 40 mg/kg i.v.
n=9 Participants
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, DZIF-10c by i.v. infusion
|
|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Patients With Any AE Within 7 d of Study Drug Administration
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post doseArea under the Curve based on serum antibody levels; 4 hour post dose collected in groups 1A-1C and 2A-2C, 1 hour post dose in group 2D (timings referring to last adminstered product); 21 day post dose only in groups 1A-1C. Geometric mean values were only calculated for groups in which at least three individuals with detectable serum levels were included.
Outcome measures
| Measure |
1A: Healthy, 50 mg Inh.
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1B: Healthy, 100 mg Inh.
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1C: Healthy, 250 mg Inh.
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
2A: Infected, 50 mg Inh.
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2B: Infected, 100 mg Inh.
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2C: Infected, 250 mg Inh.
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2D: Infected, Placebo Inh., Placebo i.v.
n=8 Participants
Double blind and randomized, SARS-CoV-2-infected, placebo by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., Placebo i.v.
n=9 Participants
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., 40 mg/kg i.v.
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, DZIF-10c by i.v. infusion
|
|---|---|---|---|---|---|---|---|---|---|
|
DZIF-10c Area Under the Curve
|
NA μg*h/ml
Geometric Coefficient of Variation NA
Data could not be calculated because DZIF-10c in serum was only detected in a single individual and only at two time points (day 3 and day 7 post dose).
|
NA μg*h/ml
Geometric Coefficient of Variation NA
Data could not be calculated because DZIF-10c in serum was only detected in a single individual who also had reactivity in the test determined to measure DZIF-10c serum levels prior to DZIF-10c administration (i.e., background reactivity that prevented accurate determination of DZIF-10c levels).
|
284 μg*h/ml
Geometric Coefficient of Variation 18.2
|
NA μg*h/ml
Geometric Coefficient of Variation NA
Data could not be calculated because DZIF-10c was not detected in serum in any of the participants.
|
199 μg*h/ml
Geometric Coefficient of Variation NA
Data calculated from single participant - therefore no coefficient of variation can be determined. No DZIF-10c in serum could be detected in the remaining two participants.
|
NA μg*h/ml
Geometric Coefficient of Variation NA
Data available from only two participants, therefore no geometric mean and coefficients of variation calculated. Individual values for AUC were 220 and 319 μg\*h/ml. DZIF-10c could not be detected in serum in the remaining individual.
|
225 μg*h/ml
Geometric Coefficient of Variation 39.2
|
174000 μg*h/ml
Geometric Coefficient of Variation 14.5
|
—
|
SECONDARY outcome
Timeframe: 0, 14, 28, 56, 90 days post doseIndividuals developing anti-drug antibodies
Outcome measures
| Measure |
1A: Healthy, 50 mg Inh.
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1B: Healthy, 100 mg Inh.
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1C: Healthy, 250 mg Inh.
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
2A: Infected, 50 mg Inh.
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2B: Infected, 100 mg Inh.
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2C: Infected, 250 mg Inh.
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2D: Infected, Placebo Inh., Placebo i.v.
n=8 Participants
Double blind and randomized, SARS-CoV-2-infected, placebo by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., Placebo i.v.
n=9 Participants
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., 40 mg/kg i.v.
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, DZIF-10c by i.v. infusion
|
|---|---|---|---|---|---|---|---|---|---|
|
Anti-Drug Antibody Development
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 3, 7, 14, 28 days post doseTime-weighted change of SARS-CoV-2 viral load from baseline in nasopharyngeal swab samples as determined by the SARS-CoV-2 E gene; based on a parametric analysis of covariance model with corresponding baseline viral load, antibody status at baseline, and treatment; determined as the adjusted mean area over the curve (AOC) for samples collected at baseline and 1, 3, 7, 14, 28 days post dose
Outcome measures
| Measure |
1A: Healthy, 50 mg Inh.
n=10 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1B: Healthy, 100 mg Inh.
n=8 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1C: Healthy, 250 mg Inh.
n=9 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
2A: Infected, 50 mg Inh.
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2B: Infected, 100 mg Inh.
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2C: Infected, 250 mg Inh.
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2D: Infected, Placebo Inh., Placebo i.v.
Double blind and randomized, SARS-CoV-2-infected, placebo by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., Placebo i.v.
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., 40 mg/kg i.v.
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, DZIF-10c by i.v. infusion
|
|---|---|---|---|---|---|---|---|---|---|
|
Time-weighted SARS-CoV-2 Viral Load Change From Baseline
Over 7 days
|
-1.932 log10 cp/ml
Standard Error 0.263
|
-2.100 log10 cp/ml
Standard Error 0.294
|
-1.716 log10 cp/ml
Standard Error 0.268
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time-weighted SARS-CoV-2 Viral Load Change From Baseline
Over 14 days
|
-2.780 log10 cp/ml
Standard Error 0.238
|
-3.044 log10 cp/ml
Standard Error 0.267
|
-2.786 log10 cp/ml
Standard Error 0.244
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time-weighted SARS-CoV-2 Viral Load Change From Baseline
Over 28 days
|
-3.616 log10 cp/ml
Standard Error 0.126
|
-3.652 log10 cp/ml
Standard Error 0.142
|
-3.652 log10 cp/ml
Standard Error 0.129
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 3, 7, 14, 28 days post doseChange of SARS-CoV-2 viral load from baseline in nasopharyngeal swab samples as determined by the SARS-CoV-2 E gene; based on Mixed Model for Repeated Measures (MMRM) with fixed effects for antibody status at BL, LOG10 (viral load) at BL and interaction with visit, treatment-by-visit interaction, and random effect for patient; samples collected at baseline and 1, 3, 7, 14, 28 days post dose
Outcome measures
| Measure |
1A: Healthy, 50 mg Inh.
n=10 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1B: Healthy, 100 mg Inh.
n=8 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1C: Healthy, 250 mg Inh.
n=9 Participants
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
2A: Infected, 50 mg Inh.
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2B: Infected, 100 mg Inh.
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2C: Infected, 250 mg Inh.
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2D: Infected, Placebo Inh., Placebo i.v.
Double blind and randomized, SARS-CoV-2-infected, placebo by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., Placebo i.v.
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., 40 mg/kg i.v.
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, DZIF-10c by i.v. infusion
|
|---|---|---|---|---|---|---|---|---|---|
|
MMRM SARS-CoV-2 Viral Load Change From Baseline
Over 7 days
|
-3.4 Adjusted log10 VL (cp/ml)
Standard Error 0.4
|
-3.4 Adjusted log10 VL (cp/ml)
Standard Error 0.5
|
-3.2 Adjusted log10 VL (cp/ml)
Standard Error 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
MMRM SARS-CoV-2 Viral Load Change From Baseline
Over 14 days
|
-4.4 Adjusted log10 VL (cp/ml)
Standard Error 0.1
|
-4.1 Adjusted log10 VL (cp/ml)
Standard Error 0.1
|
-4.4 Adjusted log10 VL (cp/ml)
Standard Error 0.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
MMRM SARS-CoV-2 Viral Load Change From Baseline
Over 28 days
|
-4.4 Adjusted log10 VL (cp/ml)
Standard Error 0.3
|
-4.3 Adjusted log10 VL (cp/ml)
Standard Error 0.3
|
-4.4 Adjusted log10 VL (cp/ml)
Standard Error 0.3
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
1A: Healthy, 50 mg Inh.
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1B: Healthy, 100 mg Inh.
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1C: Healthy, 250 mg Inh.
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2A: Infected, 50 mg Inh.
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
2B: Infected, 100 mg Inh.
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2C: Infected, 250 mg Inh.
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2D: Infected, Placebo Inh., Placebo i.v.
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
2D: Infected, 250 mg Inh., Placebo i.v.
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
2D: Infected, 250 mg Inh., 40 mg/kg i.v.
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1A: Healthy, 50 mg Inh.
n=3 participants at risk
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1B: Healthy, 100 mg Inh.
n=3 participants at risk
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
1C: Healthy, 250 mg Inh.
n=3 participants at risk
Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation
|
2A: Infected, 50 mg Inh.
n=3 participants at risk
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2B: Infected, 100 mg Inh.
n=3 participants at risk
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2C: Infected, 250 mg Inh.
n=3 participants at risk
Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation
|
2D: Infected, Placebo Inh., Placebo i.v.
n=10 participants at risk
Double blind and randomized, SARS-CoV-2-infected, placebo by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., Placebo i.v.
n=8 participants at risk
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, placebo by i.v. infusion
|
2D: Infected, 250 mg Inh., 40 mg/kg i.v.
n=9 participants at risk
Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, DZIF-10c by i.v. infusion
|
|---|---|---|---|---|---|---|---|---|---|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
12.5%
1/8 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
General disorders
Inflammation
|
33.3%
1/3 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
33.3%
1/3 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
20.0%
2/10 • Number of events 2 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
General disorders
Pain
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
20.0%
2/10 • Number of events 3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
22.2%
2/9 • Number of events 2 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
General disorders
Fatigue
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
12.5%
1/8 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
11.1%
1/9 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
General disorders
Chest pain
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
11.1%
1/9 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Psychiatric disorders
Aphasia
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
11.1%
1/9 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
10.0%
1/10 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
11.1%
1/9 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
33.3%
1/3 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
10.0%
1/10 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
33.3%
1/3 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
10.0%
1/10 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Cardiac disorders
Ventricular arrhythmia
|
33.3%
1/3 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
66.7%
2/3 • Number of events 2 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
33.3%
1/3 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
33.3%
1/3 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
66.7%
2/3 • Number of events 3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
20.0%
2/10 • Number of events 2 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
12.5%
1/8 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
33.3%
1/3 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
33.3%
1/3 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
50.0%
5/10 • Number of events 6 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
25.0%
2/8 • Number of events 2 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
11.1%
1/9 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
12.5%
1/8 • Number of events 3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
66.7%
2/3 • Number of events 2 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
33.3%
1/3 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
20.0%
2/10 • Number of events 3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
25.0%
2/8 • Number of events 2 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
33.3%
3/9 • Number of events 6 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
33.3%
1/3 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
20.0%
2/10 • Number of events 2 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
11.1%
1/9 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
11.1%
1/9 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
10.0%
1/10 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
11.1%
1/9 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
12.5%
1/8 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
12.5%
1/8 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
33.3%
1/3 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
10.0%
1/10 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
33.3%
1/3 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/10 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
12.5%
1/8 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Infections and infestations
Gonococcal infection
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
10.0%
1/10 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/3 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
10.0%
1/10 • Number of events 1 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/8 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
0.00%
0/9 • 90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Participants were queried about potential Adverse Events at all study visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publications by PIs are to be submitted to the sponsor for review at least 30 days prior to planned disclosure. Modifications suggested by the sponsor should be considered unless they affect the scientific character or neutrality of the publication. A maximum embargo period of 90 days is applicable only if disclosure would affect (potential) intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER