Trial Outcomes & Findings for This Study Tests in Healthy Korean Women Which Effects BI 409306 and a Birth-control Pill Have on Each Other (NCT NCT03193307)
NCT ID: NCT03193307
Last Updated: 2024-03-13
Results Overview
AUC0-tz , area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable concentration is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of one tablet of 25 mg BI 409306 alone (Day 29).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
PK samples were collected 10 min pre-dose and up to 72 h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29).
Results posted on
2024-03-13
Participant Flow
Open-label, two-period, fixed-sequence trial to investigate potential drug-drug interactions between BI 409306 and Microgynon® (ethinylestradiol and levonorgestrel). In run-in period, subjects were adjusted to Microgynon® treatment and in treatment period, BI 409306 and Microgynon® were either administered alone or in combination.
All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be entered to trial treatment if any one of the specific entry criteria were not met.
Participant milestones
| Measure |
Microgynon® 30 + BI 409306 Then BI 409306 Alone
Participants were administered once daily orally one coated tablet (sugar coated) of Microgynon® 30 (containing 30 microgram (μg) ethinylestradiol (EE) and 150 μg levonorgestrel (LNG)) from Day 1 to Day 21.
On Day 18 additionally to Microgynon®30, participants were also administered once daily orally one film coated tablet of 25 milligram (mg) of BI 409306 (Test 1 (T1)).
On Day 29 participants were administered once daily orally one film coated tablet of 25 mg of BI 409306 (Reference 1 (R1)).
|
|---|---|
|
Period 1 - Microgynon® 30 + BI 409306
STARTED
|
16
|
|
Period 1 - Microgynon® 30 + BI 409306
COMPLETED
|
16
|
|
Period 1 - Microgynon® 30 + BI 409306
NOT COMPLETED
|
0
|
|
Period 2 - BI 409306 Alone
STARTED
|
16
|
|
Period 2 - BI 409306 Alone
COMPLETED
|
16
|
|
Period 2 - BI 409306 Alone
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TS
Baseline characteristics by cohort
| Measure |
Microgynon® 30 + BI 409306 Then BI 409306 Alone
n=16 Participants
Participants were administered once daily orally one coated tablet (sugar coated) of Microgynon® 30 (containing 30 microgram (μg) ethinylestradiol (EE) and 150 μg levonorgestrel (LNG)) from Day 1 to Day 21.
On Day 18 additionally to Microgynon®30, participants were also administered once daily orally one film coated tablet of 25 milligram (mg) of BI 409306 (Test 1 (T1)).
On Day 29 participants were administered once daily orally one film coated tablet of 25 mg of BI 409306 (Reference 1 (R1)).
|
|---|---|
|
Age, Continuous
|
26.6 Years
STANDARD_DEVIATION 4.43 • n=5 Participants • TS
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants • TS
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants • TS
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • TS
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants • TS
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • TS
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • TS
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants • TS
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • TS
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • TS
|
PRIMARY outcome
Timeframe: PK samples were collected 10 min pre-dose and up to 72 h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29).Population: Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter value for one period to the statistical assessment and was not excluded from the study as predefined in the Trial statistical analysis plan (TSAP).
AUC0-tz , area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable concentration is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of one tablet of 25 mg BI 409306 alone (Day 29).
Outcome measures
| Measure |
BI 409306 + Microgynon® 30 (T1)
n=16 Participants
Subjects were administered orally 1 tablet of 25 milligram (mg) BI 409306 together with 1 tablet Microgynon® 30 on Day 18 (Test 1 (T1)).
|
BI 409306 Alone (R1)
n=16 Participants
Subjects were administered orally 1 tablet of 25 mg BI 409306 alone on Day 29 (Reference 1 (R1)).
|
|---|---|---|
|
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)
|
5931.13 nanomoles*hour/Litre [nmol*h/L]
Standard Error NA
Adjusted geometric standard error=1.084.
|
3871.50 nanomoles*hour/Litre [nmol*h/L]
Standard Error NA
Adjusted geometric standard error=1.084.
|
PRIMARY outcome
Timeframe: PK samples were collected 10 min pre-dose and up to 72 h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29).Population: Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter value for one period to the statistical assessment and was not excluded from the study as predefined in the Trial statistical analysis plan (TSAP).
Cmax, maximum measured concentration of BI 409306 in plasma is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of one tablet of 25 mg BI 409306 alone (Day 29).
Outcome measures
| Measure |
BI 409306 + Microgynon® 30 (T1)
n=16 Participants
Subjects were administered orally 1 tablet of 25 milligram (mg) BI 409306 together with 1 tablet Microgynon® 30 on Day 18 (Test 1 (T1)).
|
BI 409306 Alone (R1)
n=16 Participants
Subjects were administered orally 1 tablet of 25 mg BI 409306 alone on Day 29 (Reference 1 (R1)).
|
|---|---|---|
|
Maximum Measured Concentration of BI 409306 in Plasma (Cmax)
|
1786.026 nanomoles/Litre [nmol/L]
Standard Error NA
Adjusted geometric standard error=1.054.
|
1540.816 nanomoles/Litre [nmol/L]
Standard Error NA
Adjusted geometric standard error=1.054.
|
PRIMARY outcome
Timeframe: PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18).Population: Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter value for one period to the statistical assessment and was not excluded from the study as predefined in the Trial statistical analysis plan (TSAP).
AUC0-24,ss, area under the concentration-time curve of the ethinylestradiol in plasma over the time interval from 0 to 24 hour at steady state. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI 409306 (Day 18).
Outcome measures
| Measure |
BI 409306 + Microgynon® 30 (T1)
n=16 Participants
Subjects were administered orally 1 tablet of 25 milligram (mg) BI 409306 together with 1 tablet Microgynon® 30 on Day 18 (Test 1 (T1)).
|
BI 409306 Alone (R1)
n=16 Participants
Subjects were administered orally 1 tablet of 25 mg BI 409306 alone on Day 29 (Reference 1 (R1)).
|
|---|---|---|
|
Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 to 24 Hour at Steady State (AUC0-24,ss)
|
921.880 Picograms*hour/millilitre [pg*h/mL]
Standard Error NA
Adjusted geometric standard error=1.104.
|
879.521 Picograms*hour/millilitre [pg*h/mL]
Standard Error NA
Adjusted geometric standard error=1.104.
|
PRIMARY outcome
Timeframe: PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18).Population: Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter value for one period to the statistical assessment and was not excluded from the study as predefined in the Trial statistical analysis plan (TSAP).
AUC0-24,ss, area under the concentration-time curve of the levonorgestrel in plasma over the time interval from 0 to 24 hour at steady state. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI 409306 (Day 18).
Outcome measures
| Measure |
BI 409306 + Microgynon® 30 (T1)
n=16 Participants
Subjects were administered orally 1 tablet of 25 milligram (mg) BI 409306 together with 1 tablet Microgynon® 30 on Day 18 (Test 1 (T1)).
|
BI 409306 Alone (R1)
n=16 Participants
Subjects were administered orally 1 tablet of 25 mg BI 409306 alone on Day 29 (Reference 1 (R1)).
|
|---|---|---|
|
Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 to 24 Hour at Steady State (AUC0-24,ss)
|
86110.14 Picograms*hour/millilitre [pg*h/mL]
Standard Error NA
Adjusted geometric standard error=1.108.
|
83791.03 Picograms*hour/millilitre [pg*h/mL]
Standard Error NA
Adjusted geometric standard error=1.108.
|
PRIMARY outcome
Timeframe: PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18).Population: Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter value for one period to the statistical assessment and was not excluded from the study as predefined in the Trial statistical analysis plan (TSAP).
Cmax,ss, maximum measured concentration of ethinylestradiol in plasma at steady state is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI409306 (Day 18).
Outcome measures
| Measure |
BI 409306 + Microgynon® 30 (T1)
n=16 Participants
Subjects were administered orally 1 tablet of 25 milligram (mg) BI 409306 together with 1 tablet Microgynon® 30 on Day 18 (Test 1 (T1)).
|
BI 409306 Alone (R1)
n=16 Participants
Subjects were administered orally 1 tablet of 25 mg BI 409306 alone on Day 29 (Reference 1 (R1)).
|
|---|---|---|
|
Maximum Measured Concentration of Ethinylestradiol in Plasma at Steady State (Cmax,ss)
|
112.405 Picograms/millilitre [pg/mL]
Standard Error NA
Standard error is actually adjusted geometric standard error. Adjusted geometric standard error=1.089.
|
98.500 Picograms/millilitre [pg/mL]
Standard Error NA
Standard error is actually adjusted geometric standard error. Adjusted geometric standard error=1.089.
|
PRIMARY outcome
Timeframe: PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18).Population: Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter value for one period to the statistical assessment and was not excluded from the study as predefined in the Trial statistical analysis plan (TSAP).
Cmax,ss, maximum measured concentration of levonorgestrel in plasma at steady state is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI409306 (Day 18).
Outcome measures
| Measure |
BI 409306 + Microgynon® 30 (T1)
n=16 Participants
Subjects were administered orally 1 tablet of 25 milligram (mg) BI 409306 together with 1 tablet Microgynon® 30 on Day 18 (Test 1 (T1)).
|
BI 409306 Alone (R1)
n=16 Participants
Subjects were administered orally 1 tablet of 25 mg BI 409306 alone on Day 29 (Reference 1 (R1)).
|
|---|---|---|
|
Maximum Measured Concentration of Levonorgestrel in Plasma at Steady State (Cmax,ss)
|
7867.89 Picograms/millilitre [pg/mL]
Standard Error NA
Adjusted geometric standard error=1.084.
|
7107.42 Picograms/millilitre [pg/mL]
Standard Error NA
Adjusted geometric standard error=1.084.
|
SECONDARY outcome
Timeframe: PK samples were collected 10 min pre-dose and up to 72h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29).Population: Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter value for one period to the statistical assessment and was not excluded from the study as predefined in the Trial statistical analysis plan (TSAP).
AUC0-infinity, area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of 1 tablet of 25 mg BI 409306 alone (Day 29).
Outcome measures
| Measure |
BI 409306 + Microgynon® 30 (T1)
n=15 Participants
Subjects were administered orally 1 tablet of 25 milligram (mg) BI 409306 together with 1 tablet Microgynon® 30 on Day 18 (Test 1 (T1)).
|
BI 409306 Alone (R1)
n=16 Participants
Subjects were administered orally 1 tablet of 25 mg BI 409306 alone on Day 29 (Reference 1 (R1)).
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)
|
6000.32 Nanomole*hour/milllilitre [nmol*h/mL]
Standard Error NA
Adjusted geometric standard error=1.086.
|
3892.47 Nanomole*hour/milllilitre [nmol*h/mL]
Standard Error NA
Adjusted geometric standard error=1.086.
|
Adverse Events
Microgynon® 30 Alone (R2)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
BI 409306 + Microgynon® 30 (T1)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
BI 409306 Alone (R1)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Total BI409306
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Microgynon® 30 + BI 409306 Then BI 409306 Alone
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Microgynon® 30 Alone (R2)
n=16 participants at risk
Subjects were administered orally 1 tablet of Microgynon® 30 alone on Day 17 (at steady state) (Reference 2 (R2)).
|
BI 409306 + Microgynon® 30 (T1)
n=16 participants at risk
Subjects were administered orally 1 tablet of 25 milligram (mg) BI 409306 together with 1 tablet Microgynon® 30 on Day 18 (Test 1 (T1)).
|
BI 409306 Alone (R1)
n=16 participants at risk
Subjects were administered orally 1 tablet of 25 mg BI 409306 alone on Day 29 (Reference 1 (R1)).
|
Total BI409306
n=16 participants at risk
Subjects were administered orally 1 tablet of 25 mg BI 409306 alone on Day 29 or 1 tablet of 25 mg BI 409306 together with 1 tablet Microgynon® 30 on Day 18.
|
Microgynon® 30 + BI 409306 Then BI 409306 Alone
n=16 participants at risk
Participants were administered once daily orally one coated tablet (sugar coated) of Microgynon® 30 (containing 30 microgram (μg) ethinylestradiol (EE) and 150 μg levonorgestrel (LNG)) from Day 1 to Day 21.
On Day 18 additionally to Microgynon®30, participants were also administered once daily orally one film coated tablet of 25 milligram (mg) of BI 409306 (Test 1 (T1)).
On Day 29 participants were administered once daily orally one film coated tablet of 25 mg of BI 409306 (Reference 1 (R1)).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Visual brightness
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
43.8%
7/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
62.5%
10/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
62.5%
10/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
62.5%
10/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Photopsia
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
2/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
2/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
4/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
4/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
2/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
2/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
2/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
General disorders
Catheter site pain
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
General disorders
Feeling cold
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
General disorders
Vessel puncture site erythema
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Injury, poisoning and procedural complications
Tooth injury
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
2/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
2/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
2/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
18.8%
3/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
31.2%
5/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
31.2%
5/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
2/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
18.8%
3/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
18.8%
3/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
18.8%
3/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
18.8%
3/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
2/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
2/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
2/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
2/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
6.2%
1/16 • From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER