Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of BI 113608 in Healthy Asian and Caucasian Male Volunteers (NCT NCT01922349)
NCT ID: NCT01922349
Last Updated: 2017-01-20
Results Overview
Percentage of subjects with drug-related adverse events (AE) in the SRD and MRD periods combined. The investigator assessed the possible causal relationship between an AE and the trial medication.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
98 participants
Primary outcome timeframe
Up to 21 days (4 days for SRD period and 17 days for MRD period)
Results posted on
2017-01-20
Participant Flow
Participant milestones
| Measure |
Placebo
Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (Multiple rising dose (MRD) period)
|
BI 113608 - 10 mg
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg
1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 50 mg
2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
|---|---|---|---|---|
|
Single Rising Dose (SRD) Period
STARTED
|
25
|
27
|
18
|
27
|
|
Single Rising Dose (SRD) Period
COMPLETED
|
25
|
27
|
18
|
27
|
|
Single Rising Dose (SRD) Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Multiple Rising Dose (MRD) Period
STARTED
|
24
|
27
|
18
|
27
|
|
Multiple Rising Dose (MRD) Period
COMPLETED
|
24
|
27
|
18
|
26
|
|
Multiple Rising Dose (MRD) Period
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (Multiple rising dose (MRD) period)
|
BI 113608 - 10 mg
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg
1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 50 mg
2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
|---|---|---|---|---|
|
Multiple Rising Dose (MRD) Period
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of BI 113608 in Healthy Asian and Caucasian Male Volunteers
Baseline characteristics by cohort
| Measure |
Placebo
n=25 Participants
Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 10 mg
n=27 Participants
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg
n=18 Participants
1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 50 mg
n=27 Participants
2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27.8 Years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
28.5 Years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
28.3 Years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
28.5 Years
STANDARD_DEVIATION 5.2 • n=4 Participants
|
28.3 Years
STANDARD_DEVIATION 5.2 • n=21 Participants
|
|
Gender
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Gender
Male
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 21 days (4 days for SRD period and 17 days for MRD period)Population: Treated set (TS)
Percentage of subjects with drug-related adverse events (AE) in the SRD and MRD periods combined. The investigator assessed the possible causal relationship between an AE and the trial medication.
Outcome measures
| Measure |
Placebo
n=25 Participants
Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 10 mg
n=27 Participants
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg
n=18 Participants
1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 50 mg
n=27 Participants
2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg - Japanese
1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Chinese
2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
|
BI 113608 - 50 mg - Japanese
2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Caucasian
2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
|
|---|---|---|---|---|---|---|---|---|
|
Number (%) of Subjects With Drug-related Adverse Events
|
28.0 Percentage of participants
|
51.9 Percentage of participants
|
33.3 Percentage of participants
|
92.6 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.25 hours (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administrationPopulation: The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.
maximum measured concentration of the analyte in plasma after a single dose of BI 113608.
Outcome measures
| Measure |
Placebo
n=9 Participants
Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 10 mg
n=9 Participants
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg
n=9 Participants
1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 50 mg
n=9 Participants
2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg - Japanese
n=9 Participants
1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Chinese
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
|
BI 113608 - 50 mg - Japanese
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Caucasian
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
|
|---|---|---|---|---|---|---|---|---|
|
Cmax (Maximum Measured Concentration of the Analyte in Plasma)
|
45.8 nmol/L
Geometric Coefficient of Variation 71.4
|
72.7 nmol/L
Geometric Coefficient of Variation 63.6
|
38.9 nmol/L
Geometric Coefficient of Variation 40.1
|
191 nmol/L
Geometric Coefficient of Variation 55.8
|
217 nmol/L
Geometric Coefficient of Variation 37.2
|
494 nmol/L
Geometric Coefficient of Variation 36.8
|
320 nmol/L
Geometric Coefficient of Variation 71.4
|
437 nmol/L
Geometric Coefficient of Variation 28.7
|
SECONDARY outcome
Timeframe: 0.25 hours (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administrationPopulation: The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.
Time from dosing to maximum measured concentration in plasma after a single dose of BI 113608.
Outcome measures
| Measure |
Placebo
n=9 Participants
Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 10 mg
n=9 Participants
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg
n=9 Participants
1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 50 mg
n=9 Participants
2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg - Japanese
n=9 Participants
1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Chinese
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
|
BI 113608 - 50 mg - Japanese
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Caucasian
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
|
|---|---|---|---|---|---|---|---|---|
|
Tmax (Time From Dosing to Maximum Measured Concentration in Plasma)
|
1.00 hour
Interval 0.5 to 4.0
|
0.75 hour
Interval 0.5 to 4.0
|
0.75 hour
Interval 0.5 to 2.0
|
0.50 hour
Interval 0.25 to 3.0
|
0.75 hour
Interval 0.5 to 1.5
|
0.50 hour
Interval 0.5 to 4.0
|
0.75 hour
Interval 0.5 to 2.5
|
0.75 hour
Interval 0.5 to 1.0
|
SECONDARY outcome
Timeframe: 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administrationPopulation: The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after a single dose of BI 113608.
Outcome measures
| Measure |
Placebo
n=9 Participants
Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 10 mg
n=9 Participants
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg
n=9 Participants
1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 50 mg
n=9 Participants
2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg - Japanese
n=9 Participants
1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Chinese
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
|
BI 113608 - 50 mg - Japanese
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Caucasian
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)
|
199 nmol*h/L
Geometric Coefficient of Variation 39.6
|
288 nmol*h/L
Geometric Coefficient of Variation 26.8
|
196 nmol*h/L
Geometric Coefficient of Variation 20.1
|
648 nmol*h/L
Geometric Coefficient of Variation 29.9
|
775 nmol*h/L
Geometric Coefficient of Variation 28.7
|
1560 nmol*h/L
Geometric Coefficient of Variation 23.1
|
1320 nmol*h/L
Geometric Coefficient of Variation 48.7
|
1410 nmol*h/L
Geometric Coefficient of Variation 21.0
|
SECONDARY outcome
Timeframe: 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administrationPopulation: The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.
Area under the concentration-time curve of the analyte in plasma from time 0 to time of last quantifiable data point after a single dose of BI 113608.
Outcome measures
| Measure |
Placebo
n=9 Participants
Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 10 mg
n=9 Participants
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg
n=9 Participants
1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 50 mg
n=9 Participants
2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg - Japanese
n=9 Participants
1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Chinese
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
|
BI 113608 - 50 mg - Japanese
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Caucasian
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
|
|---|---|---|---|---|---|---|---|---|
|
AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma From Time 0 to Time of Last Quantifiable Data Point)
|
197 nmol*h/L
Geometric Coefficient of Variation 39.9
|
285 nmol*h/L
Geometric Coefficient of Variation 27.2
|
193 nmol*h/L
Geometric Coefficient of Variation 19.8
|
645 nmol*h/L
Geometric Coefficient of Variation 30.4
|
773 nmol*h/L
Geometric Coefficient of Variation 28.7
|
1560 nmol*h/L
Geometric Coefficient of Variation 23.2
|
1320 nmol*h/L
Geometric Coefficient of Variation 48.9
|
1400 nmol*h/L
Geometric Coefficient of Variation 20.9
|
SECONDARY outcome
Timeframe: 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administrationPopulation: PKS
Terminal half-life of the analyte in plasma after a single dose of BI 113608.
Outcome measures
| Measure |
Placebo
n=9 Participants
Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 10 mg
n=9 Participants
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg
n=9 Participants
1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 50 mg
n=9 Participants
2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg - Japanese
n=9 Participants
1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Chinese
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
|
BI 113608 - 50 mg - Japanese
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Caucasian
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
|
|---|---|---|---|---|---|---|---|---|
|
t1/2 (Terminal Half-life of the Analyte in Plasma After the First Dose)
|
12.7 hours
Geometric Coefficient of Variation 45.0
|
12.1 hours
Geometric Coefficient of Variation 29.3
|
15.4 hours
Geometric Coefficient of Variation 33.2
|
11.7 hours
Geometric Coefficient of Variation 29.8
|
10.1 hours
Geometric Coefficient of Variation 23.0
|
11.7 hours
Geometric Coefficient of Variation 18.2
|
10.7 hours
Geometric Coefficient of Variation 15.3
|
12.9 hours
Geometric Coefficient of Variation 21.8
|
SECONDARY outcome
Timeframe: 23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384hPopulation: PKS
Maximum measured concentration of the analyte in plasma at steady state
Outcome measures
| Measure |
Placebo
n=9 Participants
Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 10 mg
n=9 Participants
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg
n=9 Participants
1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 50 mg
n=9 Participants
2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg - Japanese
n=9 Participants
1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Chinese
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
|
BI 113608 - 50 mg - Japanese
n=8 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Caucasian
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
|
|---|---|---|---|---|---|---|---|---|
|
Cmax,ss
|
42.5 nmol/L
Geometric Coefficient of Variation 66.4
|
66.5 nmol/L
Geometric Coefficient of Variation 54.1
|
33.7 nmol/L
Geometric Coefficient of Variation 48.2
|
223 nmol/L
Geometric Coefficient of Variation 56.7
|
234 nmol/L
Geometric Coefficient of Variation 33.2
|
500 nmol/L
Geometric Coefficient of Variation 19.0
|
409 nmol/L
Geometric Coefficient of Variation 43.2
|
407 nmol/L
Geometric Coefficient of Variation 27.0
|
SECONDARY outcome
Timeframe: 23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384hPopulation: PKS
Time from last dosing to maximum concentration of the analyte in plasma at steady state
Outcome measures
| Measure |
Placebo
n=9 Participants
Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 10 mg
n=9 Participants
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg
n=9 Participants
1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 50 mg
n=9 Participants
2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg - Japanese
n=9 Participants
1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Chinese
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
|
BI 113608 - 50 mg - Japanese
n=8 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Caucasian
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
|
|---|---|---|---|---|---|---|---|---|
|
Tmax,ss
|
0.75 hours
Interval 0.5 to 6.0
|
0.75 hours
Interval 0.5 to 3.0
|
1.00 hours
Interval 0.5 to 4.0
|
0.75 hours
Interval 0.25 to 3.0
|
0.75 hours
Interval 0.5 to 1.5
|
0.75 hours
Interval 0.5 to 1.5
|
0.767 hours
Interval 0.75 to 4.0
|
0.75 hours
Interval 0.5 to 3.0
|
SECONDARY outcome
Timeframe: 23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384hPopulation: PKS
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau
Outcome measures
| Measure |
Placebo
n=9 Participants
Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 10 mg
n=9 Participants
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg
n=9 Participants
1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 50 mg
n=9 Participants
2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg - Japanese
n=9 Participants
1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Chinese
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
|
BI 113608 - 50 mg - Japanese
n=8 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Caucasian
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
|
|---|---|---|---|---|---|---|---|---|
|
AUCtau,ss
|
222 nmol*h/L
Geometric Coefficient of Variation 26.9
|
273 nmol*h/L
Geometric Coefficient of Variation 35.7
|
199 nmol*h/L
Geometric Coefficient of Variation 31.7
|
860 nmol*h/L
Geometric Coefficient of Variation 33.4
|
823 nmol*h/L
Geometric Coefficient of Variation 20.5
|
2000 nmol*h/L
Geometric Coefficient of Variation 6.46
|
1560 nmol*h/L
Geometric Coefficient of Variation 22.0
|
1530 nmol*h/L
Geometric Coefficient of Variation 41.5
|
SECONDARY outcome
Timeframe: 23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384hPopulation: PKS
Terminal half-life of the analyte in plasma at steady state
Outcome measures
| Measure |
Placebo
n=9 Participants
Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 10 mg
n=9 Participants
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg
n=9 Participants
1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 50 mg
n=9 Participants
2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg - Japanese
n=9 Participants
1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Chinese
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
|
BI 113608 - 50 mg - Japanese
n=8 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Caucasian
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
|
|---|---|---|---|---|---|---|---|---|
|
t1/2,ss
|
13.6 hours
Geometric Coefficient of Variation 10.4
|
15.3 hours
Geometric Coefficient of Variation 25.1
|
16.6 hours
Geometric Coefficient of Variation 51.0
|
13.2 hours
Geometric Coefficient of Variation 23.3
|
13.1 hours
Geometric Coefficient of Variation 9.43
|
13.4 hours
Geometric Coefficient of Variation 16.8
|
12.4 hours
Geometric Coefficient of Variation 6.97
|
13.7 hours
Geometric Coefficient of Variation 35.8
|
SECONDARY outcome
Timeframe: 0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,24h,36h,48h,~72h in SRD and ~24h,~72h,~120h,~168h,~216h,~228h,~264h,~276h,~312h,~312.25h,312.5h,312.75h,313h,313.5h,314h,314.5h,315h,316h,318h,320h,322h,324h,328h,336h,348h,360h,384h in MRDPopulation: PKS
Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of Cmax at steady state and after single dose
Outcome measures
| Measure |
Placebo
n=9 Participants
Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 10 mg
n=9 Participants
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg
n=9 Participants
1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 50 mg
n=9 Participants
2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg - Japanese
n=9 Participants
1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Chinese
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
|
BI 113608 - 50 mg - Japanese
n=8 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Caucasian
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
|
|---|---|---|---|---|---|---|---|---|
|
RA,Cmax (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Oral Administration Over a Uniform Dosing Interval Tau)
|
0.928 Ratio of Cmax
Geometric Coefficient of Variation 52.2
|
0.915 Ratio of Cmax
Geometric Coefficient of Variation 31.4
|
0.866 Ratio of Cmax
Geometric Coefficient of Variation 34.1
|
1.17 Ratio of Cmax
Geometric Coefficient of Variation 61.2
|
1.08 Ratio of Cmax
Geometric Coefficient of Variation 37.2
|
1.01 Ratio of Cmax
Geometric Coefficient of Variation 23.6
|
1.39 Ratio of Cmax
Geometric Coefficient of Variation 64.4
|
0.931 Ratio of Cmax
Geometric Coefficient of Variation 36.1
|
SECONDARY outcome
Timeframe: 0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,24h,36h,48h,~72h in SRD and ~24h,~72h,~120h,~168h,~216h,~228h,~264h,~276h,~312h,~312.25h,312.5h,312.75h,313h,313.5h,314h,314.5h,315h,316h,318h,320h,322h,324h,328h,336h,348h,360h,384h in MRDPopulation: PKS
Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval tau, expressed as ratio of AUC at steady state and after single dose
Outcome measures
| Measure |
Placebo
n=9 Participants
Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 10 mg
n=9 Participants
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg
n=9 Participants
1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 50 mg
n=9 Participants
2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
|
BI 113608 - 25 mg - Japanese
n=9 Participants
1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Chinese
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
|
BI 113608 - 50 mg - Japanese
n=8 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
|
BI 113608 - 50 mg - Caucasian
n=9 Participants
2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
|
|---|---|---|---|---|---|---|---|---|
|
RA,AUC (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Dose Administration Over a Uniform Dosing Interval Tau)
|
1.32 Ratio of AUC
Geometric Coefficient of Variation 23.4
|
1.11 Ratio of AUC
Geometric Coefficient of Variation 14.4
|
1.27 Ratio of AUC
Geometric Coefficient of Variation 18.1
|
1.49 Ratio of AUC
Geometric Coefficient of Variation 23.7
|
1.19 Ratio of AUC
Geometric Coefficient of Variation 18.6
|
1.42 Ratio of AUC
Geometric Coefficient of Variation 22.3
|
1.47 Ratio of AUC
Geometric Coefficient of Variation 32.8
|
1.21 Ratio of AUC
Geometric Coefficient of Variation 45.0
|
Adverse Events
Placebo- Chinese
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo- Japanese
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo- Caucasian
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 113608 - 10 mg - Chinese
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 113608 - 10 mg - Japanese
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 113608 - 10 mg - Caucasian
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
BI 113608 - 25 mg - Chinese
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BI 113608 - 25 mg - Japanese
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 113608 - 50 mg - Chinese
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
BI 113608 - 50 mg - Japanese
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BI 113608 - 50 mg - Caucasian
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo- Chinese
n=9 participants at risk
Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
|
Placebo- Japanese
n=9 participants at risk
Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
|
Placebo- Caucasian
n=7 participants at risk
Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
|
BI 113608 - 10 mg - Chinese
n=9 participants at risk
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 days (MRD period) in Chinese subjects
|
BI 113608 - 10 mg - Japanese
n=9 participants at risk
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
|
BI 113608 - 10 mg - Caucasian
n=9 participants at risk
2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
|
BI 113608 - 25 mg - Chinese
n=9 participants at risk
1 conventional tablet 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
|
BI 113608 - 25 mg - Japanese
n=9 participants at risk
1 conventional tablet 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
|
BI 113608 - 50 mg - Chinese
n=9 participants at risk
2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
|
BI 113608 - 50 mg - Japanese
n=9 participants at risk
2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
|
BI 113608 - 50 mg - Caucasian
n=9 participants at risk
2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Folliculitis
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
28.6%
2/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
88.9%
8/9 • 4 days for SRD period + 17 days for MRD period
|
44.4%
4/9 • 4 days for SRD period + 17 days for MRD period
|
88.9%
8/9 • 4 days for SRD period + 17 days for MRD period
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
14.3%
1/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
22.2%
2/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
22.2%
2/9 • 4 days for SRD period + 17 days for MRD period
|
|
Nervous system disorders
Somnolence
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
22.2%
2/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Nervous system disorders
Syncope
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
22.2%
2/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Eye disorders
Eyelid skin dryness
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
14.3%
1/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Eye disorders
Eye pain
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
14.3%
1/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
14.3%
1/7 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
44.4%
4/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
33.3%
3/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
14.3%
1/7 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
22.2%
2/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
28.6%
2/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
22.2%
2/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
66.7%
6/9 • 4 days for SRD period + 17 days for MRD period
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
28.6%
2/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
22.2%
2/9 • 4 days for SRD period + 17 days for MRD period
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
22.2%
2/9 • 4 days for SRD period + 17 days for MRD period
|
22.2%
2/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
General disorders
Application site rash
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
General disorders
Chest discomfort
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
General disorders
Chest pain
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
|
General disorders
Feeling hot
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
|
General disorders
Injection site discomfort
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
General disorders
Mucosal ulceration
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
General disorders
Pyrexia
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Investigations
Liver function test abnormal
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Investigations
Pulmonary function test decreased
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Investigations
Weight decreased
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/7 • 4 days for SRD period + 17 days for MRD period
|
11.1%
1/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
14.3%
1/7 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
0.00%
0/9 • 4 days for SRD period + 17 days for MRD period
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
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