Trial Outcomes & Findings for Evaluation of the Effect of Multiple Dosing With BI 201335 on CYP2B6 Metabolism and Effect of Multiple Dosing With Efavirenz on the Steady-state Pharmacokinetics of BI 201335 and on CYP3A4/5 Metabolism in Healthy Volunteers (NCT NCT01371006)
NCT ID: NCT01371006
Last Updated: 2015-08-03
Results Overview
Maximum plasma concentration (Cmax) of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of Efavirenz
Results posted on
2015-08-03
Participant Flow
Participant milestones
| Measure |
Group A: 240 mg Faldaprevir+50 mg Efavirenz
Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.
Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.
oral administration with water after food intake.
|
Group B: 600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam
Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.
Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.
oral administration with water after food intake.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
|
Overall Study
COMPLETED
|
13
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group A: 240 mg Faldaprevir+50 mg Efavirenz
Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.
Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.
oral administration with water after food intake.
|
Group B: 600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam
Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.
Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.
oral administration with water after food intake.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Evaluation of the Effect of Multiple Dosing With BI 201335 on CYP2B6 Metabolism and Effect of Multiple Dosing With Efavirenz on the Steady-state Pharmacokinetics of BI 201335 and on CYP3A4/5 Metabolism in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Group A: 240 mg Faldaprevir+50 mg Efavirenz
n=14 Participants
Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.
Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.
oral administration with water after food intake.
|
Group B: 600 mg Efavirenz+240 mg Feldaprevir+7.5 mg Midazolam
n=15 Participants
Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.
Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.
oral administration with water after food intake.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.4 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
33.1 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
36.1 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of EfavirenzPopulation: all subjects entered in sequence group A of the PK set. Pharmacokinetic (PK) set: This subject set included all subjects of the treated set who provided evaluable data for at least1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations.
Maximum plasma concentration (Cmax) of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Outcome measures
| Measure |
7.5 mg Midazolam+240 mg Faldaprevir
n=14 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
|
7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
n=13 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
|
Efavirenz+Faldaprevir
During treatment with Faldaprevir and single-dose Efavirenz.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
|---|---|---|---|---|---|
|
Group A - Efavirenz: Cmax
|
771.0 nmol/L
Geometric Coefficient of Variation 29.1
|
809.0 nmol/L
Geometric Coefficient of Variation 19.9
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 h after administration of EfavirenzPopulation: all subjects entered in sequence group A of the PK set.
Area under the concentration-time curve of the analyte in plasma over the time interval 0 to infinity of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Outcome measures
| Measure |
7.5 mg Midazolam+240 mg Faldaprevir
n=14 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
|
7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
n=13 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
|
Efavirenz+Faldaprevir
During treatment with Faldaprevir and single-dose Efavirenz.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
|---|---|---|---|---|---|
|
Group A - Efavirenz: AUC0-∞
|
36100.0 nmol*h/L
Geometric Coefficient of Variation 30.3
|
40700.0 nmol*h/L
Geometric Coefficient of Variation 28.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of FaldaprevirPopulation: all subjects entered in sequence group B of the PK set.
Maximum plasma concentration at steady state of Faldaprevir calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Outcome measures
| Measure |
7.5 mg Midazolam+240 mg Faldaprevir
n=15 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
|
7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
n=14 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
|
Efavirenz+Faldaprevir
During treatment with Faldaprevir and single-dose Efavirenz.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
|---|---|---|---|---|---|
|
Group B - Faldaprevir: Cmax,ss
|
24000.0 ng/mL
Geometric Coefficient of Variation 76.4
|
17200.0 ng/mL
Geometric Coefficient of Variation 111
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of FaldaprevirPopulation: all subjects entered in sequence group B of the PK set.
Area under the concentration-time curve of Faldaprevir at steady state over the time interval 0 to 12h calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Outcome measures
| Measure |
7.5 mg Midazolam+240 mg Faldaprevir
n=15 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
|
7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
n=14 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
|
Efavirenz+Faldaprevir
During treatment with Faldaprevir and single-dose Efavirenz.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
|---|---|---|---|---|---|
|
Group B - Faldaprevir: AUC0-12h,ss
|
225000.0 ng*h/mL
Geometric Coefficient of Variation 91.1
|
146000.0 ng*h/mL
Geometric Coefficient of Variation 148
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of FaldaprevirPopulation: all subjects entered in sequence group B of the PK set.
Plasma concentration 12 h after dosing of Faldaprevir at steady state calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Outcome measures
| Measure |
7.5 mg Midazolam+240 mg Faldaprevir
n=15 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
|
7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
n=13 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
|
Efavirenz+Faldaprevir
During treatment with Faldaprevir and single-dose Efavirenz.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
|---|---|---|---|---|---|
|
Group B - Faldaprevir: C12,ss
|
14700.0 ng/mL
Geometric Coefficient of Variation 119.0
|
7650.0 ng/mL
Geometric Coefficient of Variation 277.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of FaldaprevirPopulation: All patients entered in sequence group A of the PK set
Maximum plasma concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Outcome measures
| Measure |
7.5 mg Midazolam+240 mg Faldaprevir
n=13 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
|
7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
|
Efavirenz+Faldaprevir
During treatment with Faldaprevir and single-dose Efavirenz.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
|---|---|---|---|---|---|
|
Group A - Faldaprevir: Cmax,ss
|
34600.0 ng/mL
Geometric Coefficient of Variation 26.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of FaldaprevirPopulation: All patients entered in sequence sequence group A of the PK set
Time of maximum concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Outcome measures
| Measure |
7.5 mg Midazolam+240 mg Faldaprevir
n=13 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
|
7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
|
Efavirenz+Faldaprevir
During treatment with Faldaprevir and single-dose Efavirenz.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
|---|---|---|---|---|---|
|
Group A - Faldaprevir: Tmax,ss
|
3.00 hours
Full Range 0.836 • Interval 2.0 to 4.03
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of FaldaprevirPopulation: All patients entered in sequence group A of the PK set
Area under the concentration-time curve of Faldaprevir over the time interval 0-12h on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Outcome measures
| Measure |
7.5 mg Midazolam+240 mg Faldaprevir
n=13 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
|
7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
|
Efavirenz+Faldaprevir
During treatment with Faldaprevir and single-dose Efavirenz.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
|---|---|---|---|---|---|
|
Group A - Faldaprevir: AUC0-12h,ss
|
341000 ng*h/mL
Geometric Coefficient of Variation 27.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of FaldaprevirPopulation: All patients entered in sequence group A of the PK set
Plasma concentration 12 h after dosing of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Outcome measures
| Measure |
7.5 mg Midazolam+240 mg Faldaprevir
n=13 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
|
7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
|
Efavirenz+Faldaprevir
During treatment with Faldaprevir and single-dose Efavirenz.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
|---|---|---|---|---|---|
|
Group A - Faldaprevir: C12,ss
|
23900 ng/mL
Geometric Coefficient of Variation 27.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of EfavirenzPopulation: All patients entered in sequence group A of the PK set
Time of maximum concentration of Efavirenz on day 14, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Outcome measures
| Measure |
7.5 mg Midazolam+240 mg Faldaprevir
n=14 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
|
7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
|
Efavirenz+Faldaprevir
During treatment with Faldaprevir and single-dose Efavirenz.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
|---|---|---|---|---|---|
|
Group A - Efavirenz: Tmax
Day 1: Efavirenz
|
3.00 hours
Full Range 1.41 • Interval 1.5 to 4.02
|
—
|
—
|
—
|
—
|
|
Group A - Efavirenz: Tmax
Day 14: Efavirenz+Faldaprevir (N=13)
|
3.03 hours
Interval 1.0 to 4.03
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of FaldaprevirPopulation: All patients entered in sequence group B of the PK set
Time of maximum concentration of Faldaprevir on Day 9 and 10 at steady state, calculated for patients in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Outcome measures
| Measure |
7.5 mg Midazolam+240 mg Faldaprevir
n=15 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
|
7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
|
Efavirenz+Faldaprevir
During treatment with Faldaprevir and single-dose Efavirenz.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
|---|---|---|---|---|---|
|
Group B - Faldaprevir: Tmax,ss
Day 9: Midazolam+Faldaprevir
|
3.00 hours
Interval 0.0 to 4.17
|
—
|
—
|
—
|
—
|
|
Group B - Faldaprevir: Tmax,ss
Day 18: Midazolam+Faldaprevir+Efavirenz (N=14)
|
2.02 hours
Interval 1.0 to 4.03
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of MidazolamPopulation: all subjects entered in sequence group B of the PK set.
Maximum plasma concentration of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Outcome measures
| Measure |
7.5 mg Midazolam+240 mg Faldaprevir
n=15 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
|
7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
|
Efavirenz+Faldaprevir
During treatment with Faldaprevir and single-dose Efavirenz.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
|---|---|---|---|---|---|
|
Group B - Midazolam: Cmax
Day 1: Midazolam
|
110.0 nmol/L
Geometric Coefficient of Variation 45.6
|
—
|
—
|
—
|
—
|
|
Group B - Midazolam: Cmax
Day 9: Midazolam+Faldaprevir
|
121.0 nmol/L
Geometric Coefficient of Variation 46.1
|
—
|
—
|
—
|
—
|
|
Group B - Midazolam: Cmax
Day 18: Midazolam+Faldaprevir+Efavirenz (N=14)
|
44.9 nmol/L
Geometric Coefficient of Variation 101.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of MidazolamPopulation: all subjects entered in sequence group B of the PK set.
Time of maximum concentration after a single dose of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Outcome measures
| Measure |
7.5 mg Midazolam+240 mg Faldaprevir
n=15 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
|
7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
|
Efavirenz+Faldaprevir
During treatment with Faldaprevir and single-dose Efavirenz.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
|---|---|---|---|---|---|
|
Group B - Midazolam: Tmax
Day 1: Midazolam
|
1.00 hours
Full Range 47.0 • Interval 0.5 to 1.5
|
—
|
—
|
—
|
—
|
|
Group B - Midazolam: Tmax
Day 9: Midazolam+Faldaprevir
|
1.00 hours
Full Range 59.7 • Interval 0.5 to 3.0
|
—
|
—
|
—
|
—
|
|
Group B - Midazolam: Tmax
Day 18: Midazolam+Faldaprevir+Efavirenz (N=14)
|
0.74 hours
Full Range 59.0 • Interval 0.5 to 3.02
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of MidazolamPopulation: all subjects entered in sequence group B of the PK set.
Area under the concentration-time curve of of Midazolam over the time interval 0 to infinity on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Outcome measures
| Measure |
7.5 mg Midazolam+240 mg Faldaprevir
n=15 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
|
7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
|
Efavirenz+Faldaprevir
During treatment with Faldaprevir and single-dose Efavirenz.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
|---|---|---|---|---|---|
|
Group B - Midazolam: AUC0-∞
Day 1: Midazolam
|
278 nmol*h/L
Geometric Coefficient of Variation 28.3
|
—
|
—
|
—
|
—
|
|
Group B - Midazolam: AUC0-∞
Day 9: Midazolam+Faldaprevir
|
624 nmol*h/L
Geometric Coefficient of Variation 54.3
|
—
|
—
|
—
|
—
|
|
Group B - Midazolam: AUC0-∞
Day 18: Midazolam+Faldaprevir+Efavirenz (N=14)
|
110 nmol*h/L
Geometric Coefficient of Variation 88.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first treatment administration (Day 1) up to Day 24Population: treated set: All subjects who were dispensed study medication and were documented to have taken at least 1 dose of trial medication
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Outcome measures
| Measure |
7.5 mg Midazolam+240 mg Faldaprevir
n=14 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
|
7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
n=15 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
|
Efavirenz+Faldaprevir
During treatment with Faldaprevir and single-dose Efavirenz.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
|---|---|---|---|---|---|
|
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG
Weight decreased
|
1 participants
|
0 participants
|
—
|
—
|
—
|
|
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG
Hepatic enzyme increased
|
0 participants
|
1 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to 30 days after last treatment (Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24)Population: all subjects entered in sequence group A of the treated set.
Number of participants with investigator-defined drug related adverse events (AE) in sequence group A. AEs occurring up to 5 days after last intake of Faldaprevir on day 19 were assigned to Efavirenz+Faldaprevir treatment. AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
Outcome measures
| Measure |
7.5 mg Midazolam+240 mg Faldaprevir
n=14 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
|
7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
n=14 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
|
Efavirenz+Faldaprevir
n=13 Participants
During treatment with Faldaprevir and single-dose Efavirenz.
|
Total On-treatment
n=14 Participants
Total number of participants with drug related adverse events during treatment.
|
Total On-treatment
Total number of participants with drug related adverse events during treatment.
|
|---|---|---|---|---|---|
|
Group A - Number of Participants With Drug Related Adverse Events
|
2 participants
|
13 participants
|
11 participants
|
13 participants
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to 30 days after last treatment (Days 1,2,6,8,9,10,11,14,17,18,19,24)Population: all subjects entered in sequence group B of the treated set.
Number of participants with investigator-defined drug related adverse events (AE) in sequence group B. AEs occurring up to 5 days after last intake of Faldaprevir were assigned to Faldaprevir+Midazolam+Efavirenz treatment. AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
Outcome measures
| Measure |
7.5 mg Midazolam+240 mg Faldaprevir
n=15 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
|
7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
n=15 Participants
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
|
Efavirenz+Faldaprevir
n=15 Participants
During treatment with Faldaprevir and single-dose Efavirenz.
|
Total On-treatment
n=15 Participants
Total number of participants with drug related adverse events during treatment.
|
Total On-treatment
n=15 Participants
Total number of participants with drug related adverse events during treatment.
|
|---|---|---|---|---|---|
|
Group B - Number of Participants With Drug Related Adverse Events
|
1 participants
|
14 participants
|
3 participants
|
14 participants
|
15 participants
|
Adverse Events
Group A: Efavirenz
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group A: Faldaprevir
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Group A: Faldaprevir+Efavirenz
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Group B: Midazolam
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group B: Faldaprevir
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Group B: Faldaprevir+Midazolam
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group B: Faldaprevir+Midazolam+Efavirenz
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 |
Group A: Efavirenz
n=14 participants at risk
Treatment with single-dose Efavirenz in Group A.
|
Group A: Faldaprevir
n=14 participants at risk
During treatment with Faldaprevir in Group A.
|
Group A: Faldaprevir+Efavirenz
n=13 participants at risk
During treatment with Faldaprevir and single-dose Efavirenz in Group A.
|
Group B: Midazolam
n=15 participants at risk
Treatment with single-dose Midazolam in Group B.
|
Group B: Faldaprevir
n=15 participants at risk
During treatment with Faldaprevir in Group B.
|
Group B: Faldaprevir+Midazolam
n=15 participants at risk
During treatment with Faldaprevir and single-dose Midazolam in Group B.
|
Group B: Faldaprevir+Midazolam+Efavirenz
n=15 participants at risk
During treatment with Faldaprevir, Efavirenz, and single-dose Midazolam in Group B.
|
|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Hypnagogic hallucination
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
7.7%
1/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
26.7%
4/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
13.3%
2/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
13.3%
2/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
21.4%
3/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
26.7%
4/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
66.7%
10/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
21.4%
3/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
38.5%
5/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
20.0%
3/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
20.0%
3/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Nervous system disorders
Circadian rhythm sleep disorder
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
7.1%
1/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
7.1%
1/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Eye disorders
Ocular icterus
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
28.6%
4/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
33.3%
5/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
7.7%
1/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
7.1%
1/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
7.1%
1/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
7.1%
1/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
7.1%
1/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
42.9%
6/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
23.1%
3/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
40.0%
6/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
20.0%
3/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
35.7%
5/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
15.4%
2/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
13.3%
2/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
21.4%
3/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
13.3%
2/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
14.3%
2/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
7.7%
1/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
7.1%
1/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
7.7%
1/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
13.3%
2/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
7.1%
1/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
7.1%
1/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
7.7%
1/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
40.0%
6/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
46.7%
7/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Skin and subcutaneous tissue disorders
Rash maculo?papular
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
15.4%
2/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
7.7%
1/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
7.7%
1/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
7.7%
1/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
13.3%
2/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
General disorders
Fatigue
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
20.0%
3/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
General disorders
Feeling hot
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
13.3%
2/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
General disorders
Malaise
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
General disorders
Pyrexia
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Investigations
Weight decreased
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
7.1%
1/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/14 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
30.8%
4/13 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
6.7%
1/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
0.00%
0/15 • From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
|
Additional Information
Boehringer Ingelheim Call Center
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