Trial Outcomes & Findings for Influence of Fluvoxamine on the Pharmacokinetics of BI 409306 (NCT NCT02853136)
NCT ID: NCT02853136
Last Updated: 2024-08-21
Results Overview
This outcome measured the area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) in the main phase of the trial (10mg BI 409306 + 100 mg Fluvoxamine (T2) and 10 mg BI 409306 (R2)), as defined in the clinical trial protocol. The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
-2:00h (hours: minutes) before drug administration and 0:20h, 0:30h, 0:45h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.
Results posted on
2024-08-21
Participant Flow
This trial was a randomised, open-label, two-treatment, two-sequence, two period crossover trial in healthy male and female subjects in order to compare the test treatment (T1) to the reference treatment (R1) in the pilot phase and the test treatment (T2) to the reference treatment (R2) in the main phase. Abbreviations used: R1 (Reference 1), R2 (Reference 2), T1 (Test 1), T2 (Test 2), SD (Standard Deviation).
Participant milestones
| Measure |
3 mg BI 409306 (R1)/3 mg BI 409306 + 100 mg Fluvoxamine (T1)
The subjects were administered 3 milligram (mg) BI 409306 Powder for Oral Solution (PfOS) single dose for one day in the pilot phase, taken as 6 mL of 0.5 mg/mL BI 409306 solved in 5 mg/mL (milliliter) tartaric acid orally with 240 mL of water after an overnight fast of at least 10h, followed by 3 mg BI 409306 PfOS single dose for one day together with 100 mg Fluvoxamine (Fevarin®) film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h.
Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.
There was a washout of at least 3 days after administration of BI 409306 in R1.
|
3 mg BI 409306 + 100 mg Fluvoxamine (T1)/3 mg BI 409306 (R1)
The subjects were administered 3 mg BI 409306 PfOS single dose for one day in the pilot phase together with 100 mg Fluvoxamine (Fevarin®) film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h, followed by 3 mg BI 409306 PfOS single dose for one day orally with 240 mL of water after an overnight fast of at least 10h.
Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.
There was a washout of at least 6 days after combined administration of BI 409306 and Fluvoxamine in T1.
|
10 mg BI 409306 (R2)/10 mg BI 409306 + 100 mg Fluvoxamine (T2)
The subjects were administered 10 mg BI 409306 film-coated tablet single dose for one day in the main phase orally with 240 mL of water after an overnight fast of at least 10h, followed by 10 mg BI 409306 film-coated tablet single dose for one day together with 100 mg Fluvoxamine (Fevarin®) film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h.
Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.
There was a washout of at least 3 days after administration of BI 409306 in R2.
|
10 mg BI 409306 + 100 mg Fluvoxamine (T2)/10 mg BI 409306 (R2)
The subjects were administered 10 mg BI 409306 film-coated tablet single dose for one day in the main phase together with 100 mg Fluvoxamine (Fevarin®) film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h, followed by 10 mg BI 409306 single dose film-coated tablet for one day orally with 240 mL of water after an overnight fast of at least 10h.
Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.
There was a washout of at least 6 days after combined administration of BI 409306 and Fluvoxamine in T2.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
2
|
2
|
7
|
7
|
|
Period 1
COMPLETED
|
2
|
2
|
7
|
7
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Wash-out
STARTED
|
2
|
2
|
7
|
7
|
|
Wash-out
COMPLETED
|
2
|
2
|
7
|
6
|
|
Wash-out
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Period 2
STARTED
|
2
|
2
|
7
|
6
|
|
Period 2
COMPLETED
|
2
|
2
|
7
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
3 mg BI 409306 (R1)/3 mg BI 409306 + 100 mg Fluvoxamine (T1)
The subjects were administered 3 milligram (mg) BI 409306 Powder for Oral Solution (PfOS) single dose for one day in the pilot phase, taken as 6 mL of 0.5 mg/mL BI 409306 solved in 5 mg/mL (milliliter) tartaric acid orally with 240 mL of water after an overnight fast of at least 10h, followed by 3 mg BI 409306 PfOS single dose for one day together with 100 mg Fluvoxamine (Fevarin®) film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h.
Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.
There was a washout of at least 3 days after administration of BI 409306 in R1.
|
3 mg BI 409306 + 100 mg Fluvoxamine (T1)/3 mg BI 409306 (R1)
The subjects were administered 3 mg BI 409306 PfOS single dose for one day in the pilot phase together with 100 mg Fluvoxamine (Fevarin®) film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h, followed by 3 mg BI 409306 PfOS single dose for one day orally with 240 mL of water after an overnight fast of at least 10h.
Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.
There was a washout of at least 6 days after combined administration of BI 409306 and Fluvoxamine in T1.
|
10 mg BI 409306 (R2)/10 mg BI 409306 + 100 mg Fluvoxamine (T2)
The subjects were administered 10 mg BI 409306 film-coated tablet single dose for one day in the main phase orally with 240 mL of water after an overnight fast of at least 10h, followed by 10 mg BI 409306 film-coated tablet single dose for one day together with 100 mg Fluvoxamine (Fevarin®) film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h.
Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.
There was a washout of at least 3 days after administration of BI 409306 in R2.
|
10 mg BI 409306 + 100 mg Fluvoxamine (T2)/10 mg BI 409306 (R2)
The subjects were administered 10 mg BI 409306 film-coated tablet single dose for one day in the main phase together with 100 mg Fluvoxamine (Fevarin®) film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h, followed by 10 mg BI 409306 single dose film-coated tablet for one day orally with 240 mL of water after an overnight fast of at least 10h.
Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.
There was a washout of at least 6 days after combined administration of BI 409306 and Fluvoxamine in T2.
|
|---|---|---|---|---|
|
Wash-out
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Influence of Fluvoxamine on the Pharmacokinetics of BI 409306
Baseline characteristics by cohort
| Measure |
3 mg BI 409306 (R1)/3 mg BI 409306 + 100 mg Fluvoxamine (T1)
n=2 Participants
The subjects were administered 3 milligram (mg) BI 409306 Powder for Oral Solution (PfOS) single dose for one day in the pilot phase, taken as 6 mL of 0.5 mg/mL BI 409306 solved in 5 mg/mL (milliliter) tartaric acid orally with 240 mL of water after an overnight fast of at least 10h, followed by 3 mg BI 409306 PfOS single dose for one day together with 100 mg Fluvoxamine (Fevarin®) film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h.
Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.
There was a washout of at least 3 days after administration of BI 409306 in R1.
|
3 mg BI 409306 + 100 mg Fluvoxamine (T1)/3 mg BI 409306 (R1)
n=2 Participants
The subjects were administered 3 mg BI 409306 PfOS single dose for one day in the pilot phase together with 100 mg Fluvoxamine (Fevarin®) film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h, followed by 3 mg BI 409306 PfOS single dose for one day orally with 240 mL of water after an overnight fast of at least 10h.
Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.
There was a washout of at least 6 days after combined administration of BI 409306 and Fluvoxamine in T1.
|
10 mg BI 409306 (R2)/10 mg BI 409306 + 100 mg Fluvoxamine (T2)
n=7 Participants
The subjects were administered 10 mg BI 409306 film-coated tablet single dose for one day in the main phase orally with 240 mL of water after an overnight fast of at least 10h, followed by 10 mg BI 409306 film-coated tablet single dose for one day together with 100 mg Fluvoxamine (Fevarin®) film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h.
Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.
There was a washout of at least 3 days after administration of BI 409306 in R2.
|
10 mg BI 409306 + 100 mg Fluvoxamine (T2)/10 mg BI 409306 (R2)
n=7 Participants
The subjects were administered 10 mg BI 409306 film-coated tablet single dose for one day in the main phase together with 100 mg Fluvoxamine (Fevarin®) film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h, followed by 10 mg BI 409306 single dose film-coated tablet for one day orally with 240 mL of water after an overnight fast of at least 10h.
Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.
There was a washout of at least 6 days after combined administration of BI 409306 and Fluvoxamine in T2.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.0 Years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
41.0 Years
STANDARD_DEVIATION 1.4 • n=107 Participants
|
37.4 Years
STANDARD_DEVIATION 10.6 • n=206 Participants
|
36.9 Years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
37.4 Years
STANDARD_DEVIATION 7.7 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: -2:00h (hours: minutes) before drug administration and 0:20h, 0:30h, 0:45h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.Population: Pharmacokinetic (PK) analysis set (PKS) restricted to the main phase of the trial: Plasma and urine concentration data and parameters of a subject in the main phase of the trial were included in the statistical PK analyses if they were not flagged for exclusion due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.
This outcome measured the area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) in the main phase of the trial (10mg BI 409306 + 100 mg Fluvoxamine (T2) and 10 mg BI 409306 (R2)), as defined in the clinical trial protocol. The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Outcome measures
| Measure |
10 mg BI 409306 + 100 mg Fluvoxamine (T2)
n=14 Participants
The subjects were administered 10 mg BI 409306 film-coated tablet single dose for one day together with 100 mg Fluvoxamine (Fevarin®) film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h. Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.
|
10 mg BI 409306 (R2)
n=13 Participants
The subjects were administered 10 mg BI 409306 film-coated tablet single dose for one day orally with 240 mL of water after an overnight fast of at least 10h.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
5441.83 nanomole (nmol)* hour (h)/Liter (L)
Standard Error NA
Adjusted geometric standard error = 1.178
|
175.10 nanomole (nmol)* hour (h)/Liter (L)
Standard Error NA
Adjusted geometric standard error = 1.184
|
PRIMARY outcome
Timeframe: -2:00h (hours: minutes) before drug administration and 0:20h, 0:30h, 0:45h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.Population: Pharmacokinetic (PK) analysis set (PKS) restricted to the main phase of the trial: Plasma and urine concentration data and parameters of a subject in the main phase of the trial were included in the statistical PK analyses if they were not flagged for exclusion due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.
This outcome measure presents the maximum measured concentration of BI 409306 in plasma in the main phase of the trial (10mg BI 409306 + 100 mg Fluvoxamine (T2) and 10 mg BI 409306 (R2)), as defined in the clinical trial protocol. The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Outcome measures
| Measure |
10 mg BI 409306 + 100 mg Fluvoxamine (T2)
n=14 Participants
The subjects were administered 10 mg BI 409306 film-coated tablet single dose for one day together with 100 mg Fluvoxamine (Fevarin®) film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h. Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.
|
10 mg BI 409306 (R2)
n=13 Participants
The subjects were administered 10 mg BI 409306 film-coated tablet single dose for one day orally with 240 mL of water after an overnight fast of at least 10h.
|
|---|---|---|
|
Maximum Measured Concentration of BI 409306 in Plasma (Cmax)
|
660.011 nmol/L
Standard Error NA
Adjusted geometric standard error = 1.136
|
100.153 nmol/L
Standard Error NA
Adjusted geometric standard error = 1.143
|
SECONDARY outcome
Timeframe: -2:00h (hours: minutes) before drug administration and 0:20h, 0:30h, 0:45h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.Population: Pharmacokinetic (PK) analysis set (PKS) restricted to the main phase of the trial: Plasma and urine concentration data and parameters of a subject in the main phase of the trial were included in the statistical PK analyses if they were not flagged for exclusion due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.
This outcome measure presents AUC0-infinity (area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity) in the main phase of the trial (10mg BI 409306 + 100 mg Fluvoxamine (T2) and 10 mg BI 409306 (R2)), as defined in the clinical trial protocol. The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Outcome measures
| Measure |
10 mg BI 409306 + 100 mg Fluvoxamine (T2)
n=14 Participants
The subjects were administered 10 mg BI 409306 film-coated tablet single dose for one day together with 100 mg Fluvoxamine (Fevarin®) film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h. Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.
|
10 mg BI 409306 (R2)
n=13 Participants
The subjects were administered 10 mg BI 409306 film-coated tablet single dose for one day orally with 240 mL of water after an overnight fast of at least 10h.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
|
5450.03 nmol*h/L
Standard Error NA
Adjusted geometric standard error = 1.178
|
175.61 nmol*h/L
Standard Error NA
Adjusted geometric standard error = 1.184
|
Adverse Events
3 mg BI 409306 (R1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pilot Phase: Loading Fluvoxamine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
3 mg BI 409306 + 100 mg Fluvoxamine (T1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
10 mg BI 409306 (R2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Main Phase: Loading Fluvoxamine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
10 mg BI 409306 + 100 mg Fluvoxamine (T2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
3 mg BI 409306 (R1)
n=4 participants at risk
The subjects were administered 3 mg BI 409306 PfOS orally with 240 mL of water after an overnight fast of at least 10h. The Adverse Event (AE) assignment period for this treatment lasted from the time of the administration of the single dose of BI 409306 until the end of the Residual Effect Period (REP) (24h).
|
Pilot Phase: Loading Fluvoxamine
n=4 participants at risk
The subjects were administered Fluvoxamine over 3 days orally with 240 mL of water after an overnight fast of at least 10h. The AE assignment period for this treatment lasted from the first Fluvoxamine dose given over 3 days and ended with the time of the administration of a single dose of BI 409306 together with Fluvoxamine.
|
3 mg BI 409306 + 100 mg Fluvoxamine (T1)
n=4 participants at risk
The subjects were administered 3 mg BI 409306 PfOS single dose for one day together with 100 mg Fluvoxamine (Fevarin®) film-coated tablet orally with 240 mL of water after an overnight fast of at least 10h. The AE assignment period for this treatment lasted from the time of the administration of the single dose of BI 409306 together with Fluvoxamine till the end of the REP (96h).
|
10 mg BI 409306 (R2)
n=13 participants at risk
The subjects were administered 10 mg BI 409306 film-coated tablet single dose orally with 240 mL of water after an overnight fast of at least 10h for one day. The AE assignment period for this treatment lasted from the time of the administration of the single dose of BI 409306 until the end of the REP (24h).
|
Main Phase: Loading Fluvoxamine
n=14 participants at risk
The subjects were administered Fluvoxamine over 3 days orally with 240 mL of water after an overnight fast of at least 10h. The AE assignment period for this treatment lasted from the time of the administration of the Fluvoxamine dose given over 3 days and ended with the time of the administration of a single dose of BI 409306 together with Fluvoxamine.
|
10 mg BI 409306 + 100 mg Fluvoxamine (T2)
n=14 participants at risk
The subjects were administered 10 mg BI 409306 film-coated tablet single dose for one day together with 100 mg Fluvoxamine (Fevarin®) film-coated tablet orally with 240 mL of water after an overnight fast of at least 10h. The AE assignment period for this treatment lasted from the time of the administration of a single dose of BI 409306 together with Fluvoxamine till the end of the REP (96h).
|
|---|---|---|---|---|---|---|
|
Eye disorders
Dry eye
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
7.1%
1/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
7.1%
1/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
7.1%
1/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
7.1%
1/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
7.1%
1/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
7.1%
1/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
28.6%
4/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
7.1%
1/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
|
General disorders
Sluggishness
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
25.0%
1/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
7.1%
1/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
7.1%
1/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
7.1%
1/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
25.0%
1/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
25.0%
1/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
14.3%
2/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
25.0%
1/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
21.4%
3/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
7.1%
1/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
7.1%
1/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
7.1%
1/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
7.1%
1/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/4 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/13 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
7.1%
1/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
0.00%
0/14 • From first drug administration until 4 days after last drug, up to 8.71 weeks.
Treated Set (TS): This subject set included all subjects in the Randomised Set (all subjects who were randomised, i.e. who had been assigned a study subject number, whether treated or not) who were documented to have received one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place