Trial Outcomes & Findings for Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced (NCT NCT00793793)
NCT ID: NCT00793793
Last Updated: 2018-09-05
Results Overview
Efficacy endpoint: VR (virologic response) of \>=2 log10 reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) from baseline at any time up to Day 14 (naïve patients) or Day 28 (experienced patients).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
96 participants
Primary outcome timeframe
Baseline and up to 4 weeks
Results posted on
2018-09-05
Participant Flow
Participant milestones
| Measure |
Treatment Naive (TN): Placebo
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
|
Treatment Naive(TN): 20mg Per Day (QD)
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 120 mg QD
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg Twice a Day (BID) SGC
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
7
|
7
|
6
|
6
|
7
|
6
|
15
|
15
|
6
|
7
|
|
Overall Study
COMPLETED
|
8
|
5
|
5
|
4
|
4
|
4
|
3
|
6
|
6
|
6
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
3
|
2
|
2
|
4
|
0
|
9
|
9
|
3
|
6
|
Reasons for withdrawal
| Measure |
Treatment Naive (TN): Placebo
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
|
Treatment Naive(TN): 20mg Per Day (QD)
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 120 mg QD
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg Twice a Day (BID) SGC
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
reason not specified
|
0
|
1
|
0
|
1
|
1
|
1
|
2
|
0
|
7
|
6
|
2
|
4
|
Baseline Characteristics
Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced
Baseline characteristics by cohort
| Measure |
Treatment Naive (TN): Placebo
n=8 Participants
TN patient to receive Placebo + PegIFN/RBV for 28 days
|
TN: 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.88 years
STANDARD_DEVIATION 8.36 • n=93 Participants
|
51.00 years
STANDARD_DEVIATION 7.97 • n=4 Participants
|
47.14 years
STANDARD_DEVIATION 13.84 • n=27 Participants
|
48.57 years
STANDARD_DEVIATION 16.31 • n=483 Participants
|
47.83 years
STANDARD_DEVIATION 9.26 • n=36 Participants
|
46.83 years
STANDARD_DEVIATION 11.82 • n=10 Participants
|
46.71 years
STANDARD_DEVIATION 4.79 • n=115 Participants
|
49.33 years
STANDARD_DEVIATION 10.11 • n=40 Participants
|
50.93 years
STANDARD_DEVIATION 8.13 • n=8 Participants
|
48.93 years
STANDARD_DEVIATION 13.10 • n=62 Participants
|
53.67 years
STANDARD_DEVIATION 5.32 • n=95 Participants
|
53.57 years
STANDARD_DEVIATION 8.36 • n=129 Participants
|
49.59 years
STANDARD_DEVIATION 10.08 • n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
2 Participants
n=129 Participants
|
30 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
10 Participants
n=8 Participants
|
8 Participants
n=62 Participants
|
5 Participants
n=95 Participants
|
5 Participants
n=129 Participants
|
66 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 4 weeksPopulation: Full Analysis Set (FAS): All randomized TN patients and treatment experienced patients who were dispensed trial medication and were documented to have taken at least 1 dose of trial medication.
Efficacy endpoint: VR (virologic response) of \>=2 log10 reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) from baseline at any time up to Day 14 (naïve patients) or Day 28 (experienced patients).
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=8 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)
|
100.00 percentage of responders
Interval 63.058 to 100.0
|
100.00 percentage of responders
Interval 59.038 to 100.0
|
100.00 percentage of responders
Interval 79.409 to 100.0
|
100.00 percentage of responders
Interval 79.409 to 100.0
|
100.00 percentage of responders
Interval 59.038 to 100.0
|
100.00 percentage of responders
Interval 63.058 to 100.0
|
0.00 percentage of responders
Interval 0.0 to 33.627
|
83.33 percentage of responders
Interval 42.128 to 96.331
|
100.00 percentage of responders
Interval 63.058 to 100.0
|
100.00 percentage of responders
Interval 63.058 to 100.0
|
100.00 percentage of responders
Interval 59.038 to 100.0
|
100.00 percentage of responders
Interval 59.038 to 100.0
|
PRIMARY outcome
Timeframe: from day 1 and up to 4 weeks + 4 days washoutPopulation: Treated Set (TS): This patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment regardless of randomization.
Occurrence of Adverse Events (AEs) during BI201335 + washout period. For placebo patients include all AEs through 30 days after trial discontinuation.
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=8 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Occurrence of Adverse Events (AEs) During BI201335 + Washout Period
|
100.0 percentage of participants with AEs
|
100.0 percentage of participants with AEs
|
100.0 percentage of participants with AEs
|
100.0 percentage of participants with AEs
|
100.0 percentage of participants with AEs
|
100.0 percentage of participants with AEs
|
62.5 percentage of participants with AEs
|
100.0 percentage of participants with AEs
|
100.0 percentage of participants with AEs
|
57.1 percentage of participants with AEs
|
100.0 percentage of participants with AEs
|
100.0 percentage of participants with AEs
|
PRIMARY outcome
Timeframe: from day 1 and up to 4 weeks + 4 days washoutPopulation: TS
Occurrence of Serious Adverse Events (SAEs)during BI201335 or BI201335+ washout period. For placebo patients include all SAEs through 30 days after trial discontinuation.
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=8 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period
|
0.0 percentage of participants with SAEs
|
0.0 percentage of participants with SAEs
|
0.0 percentage of participants with SAEs
|
0.0 percentage of participants with SAEs
|
0.0 percentage of participants with SAEs
|
28.6 percentage of participants with SAEs
|
0.0 percentage of participants with SAEs
|
16.7 percentage of participants with SAEs
|
14.3 percentage of participants with SAEs
|
0.0 percentage of participants with SAEs
|
0.0 percentage of participants with SAEs
|
0.0 percentage of participants with SAEs
|
PRIMARY outcome
Timeframe: Baseline and up to 4 weeksPopulation: TS
Occurrence of laboratory test abnormalities and with respect to Division of AIDS (DAIDS) classification and laboratory test values change over time. ALT=Alanine transaminase (SGPT), AST=Aspartate transaminase (SGOT).
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=8 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time
Uric acid increase, with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
1 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
|
Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time
Triglyceride increase, with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
1 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
1 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
|
Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time
ALT/GPT SGPT increase, with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
1 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
1 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
|
Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time
AST/GOT SGOT increase, with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
2 participants with grade 3 or 4 abnormal
|
1 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
1 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
|
Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time
Lipase increase, with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
1 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
|
Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time
Bilirubin total increa, with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
1 participants with grade 3 or 4 abnormal
|
8 participants with grade 3 or 4 abnormal
|
12 participants with grade 3 or 4 abnormal
|
5 participants with grade 3 or 4 abnormal
|
5 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
1 participants with grade 3 or 4 abnormal
|
2 participants with grade 3 or 4 abnormal
|
0 participants with grade 3 or 4 abnormal
|
SECONDARY outcome
Timeframe: Baseline and up to 4 weeksPopulation: FAS (as randomised)
Maximum viral load reduction from baseline up to Day 14 for treatment-naïve patients and Day 28 treatment for treatment-experienced patients.
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=8 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients
|
-5.244 log10 IU/mL
Interval -5.796 to -4.035
|
-5.334 log10 IU/mL
Interval -5.692 to -4.916
|
-5.246 log10 IU/mL
Interval -5.621 to -5.133
|
-5.404 log10 IU/mL
Interval -5.469 to -4.936
|
-4.841 log10 IU/mL
Interval -5.322 to -4.763
|
-5.476 log10 IU/mL
Interval -5.544 to -3.853
|
-0.060 log10 IU/mL
Interval -0.216 to 0.012
|
-3.049 log10 IU/mL
Interval -3.376 to -2.181
|
-3.624 log10 IU/mL
Interval -3.744 to -3.359
|
-3.740 log10 IU/mL
Interval -3.869 to -3.426
|
-4.413 log10 IU/mL
Interval -4.438 to -3.943
|
-5.023 log10 IU/mL
Interval -5.15 to -4.342
|
SECONDARY outcome
Timeframe: Baseline and up to 4 weeksPopulation: FAS (as randomised) including patients with available viral load data.
Change from baseline in viral load on Day 14 for treatment-naïve patients and on Day 28 treatment for treatment-experienced patients.
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=5 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=8 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients
|
-5.244 Log10 IU/mL
Interval -5.8 to -4.035
|
-5.386 Log10 IU/mL
Interval -5.692 to -5.283
|
-5.246 Log10 IU/mL
Interval -5.621 to -5.133
|
-5.404 Log10 IU/mL
Interval -5.469 to -4.797
|
-4.782 Log10 IU/mL
Interval -5.322 to -4.628
|
-5.497 Log10 IU/mL
Interval -5.544 to -5.3
|
0.209 Log10 IU/mL
Interval 0.165 to 0.321
|
-1.226 Log10 IU/mL
Interval -1.492 to -0.831
|
-1.539 Log10 IU/mL
Interval -2.885 to -0.782
|
-0.781 Log10 IU/mL
Interval -1.967 to -0.046
|
-2.449 Log10 IU/mL
Interval -3.502 to -1.36
|
-5.023 Log10 IU/mL
Interval -5.15 to -3.049
|
SECONDARY outcome
Timeframe: week 4Population: FAS (as randomized)
Rapid virologic response (RVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) on Day 28 for all patients.
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=8 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Rapid Virologic Response (RVR)
|
14.29 percentage of responders
Interval 3.185 to 52.651
|
16.67 percentage of responders
Interval 3.669 to 57.872
|
26.67 percentage of responders
Interval 11.017 to 52.377
|
26.67 percentage of responders
Interval 11.017 to 52.377
|
66.67 percentage of responders
Interval 29.042 to 90.101
|
14.29 percentage of responders
Interval 3.185 to 52.651
|
0.00 percentage of responders
Interval 0.0 to 33.627
|
0.00 percentage of responders
Interval 0.0 to 40.962
|
28.57 percentage of responders
Interval 8.523 to 65.086
|
14.29 percentage of responders
Interval 3.185 to 52.651
|
16.67 percentage of responders
Interval 3.669 to 57.872
|
33.33 percentage of responders
Interval 9.899 to 70.958
|
SECONDARY outcome
Timeframe: week 12Population: FAS
Early Virologic Response (EVR): \>=2 log10 reduction in plasma HCV RNA level from baseline at week 12 (day 84)
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=8 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Early Virologic Response (EVR)
|
71.4 percentage of responders
|
100.0 percentage of responders
|
86.7 percentage of responders
|
86.7 percentage of responders
|
100.0 percentage of responders
|
71.4 percentage of responders
|
0.0 percentage of responders
|
100.0 percentage of responders
|
100.0 percentage of responders
|
85.7 percentage of responders
|
83.3 percentage of responders
|
83.3 percentage of responders
|
SECONDARY outcome
Timeframe: week 4 and week 12Population: FAS
VL (Viral load) below the limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) at 4 weeks and below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at 12 weeks
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=8 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Complete EVR1 (cEVR1)
|
57.1 percentage of responders
|
83.3 percentage of responders
|
53.3 percentage of responders
|
60.0 percentage of responders
|
83.3 percentage of responders
|
57.1 percentage of responders
|
0.0 percentage of responders
|
16.7 percentage of responders
|
28.6 percentage of responders
|
28.6 percentage of responders
|
50.0 percentage of responders
|
50.0 percentage of responders
|
SECONDARY outcome
Timeframe: week 4 and week 12Population: FAS
VL below the limit of detection at both 4 weeks and 12 weeks
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=8 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Complete EVR2 (cEVR2)
|
14.3 percentage of responders
|
16.7 percentage of responders
|
33.3 percentage of responders
|
20.0 percentage of responders
|
33.3 percentage of responders
|
28.6 percentage of responders
|
0.0 percentage of responders
|
0.0 percentage of responders
|
28.6 percentage of responders
|
14.3 percentage of responders
|
33.3 percentage of responders
|
50.0 percentage of responders
|
SECONDARY outcome
Timeframe: week 48Population: FAS
End of Treatment Response (ETR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 48 (Day 336).
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=8 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
End of Treatment Response (ETR)
|
57.1 percentage of responders
|
66.7 percentage of responders
|
53.3 percentage of responders
|
40.0 percentage of responders
|
50.0 percentage of responders
|
14.3 percentage of responders
|
0.0 percentage of responders
|
83.3 percentage of responders
|
57.1 percentage of responders
|
57.1 percentage of responders
|
66.7 percentage of responders
|
33.3 percentage of responders
|
SECONDARY outcome
Timeframe: week 72Population: FAS
Sustained Virologic Response (SVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 72 (Day 504).
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=8 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sustained Virologic Response (SVR)
|
42.9 percentage of responders
|
50.0 percentage of responders
|
46.7 percentage of responders
|
40.0 percentage of responders
|
50.0 percentage of responders
|
14.3 percentage of responders
|
0.0 percentage of responders
|
50.0 percentage of responders
|
42.9 percentage of responders
|
42.9 percentage of responders
|
50.0 percentage of responders
|
50.0 percentage of responders
|
SECONDARY outcome
Timeframe: from day 1 and up to 4 weeksPopulation: FAS
Achievement of an HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) over time
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=8 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Achievement of an HCV RNA Level Below the Limit of Detection Over Time
|
14.3 percentage of participants
|
16.7 percentage of participants
|
26.7 percentage of participants
|
26.7 percentage of participants
|
66.7 percentage of participants
|
14.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
28.6 percentage of participants
|
14.3 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: from day 1 and up to 4 weeksPopulation: FAS
Achievement of an HCV RNA Level Below the Limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) Over Time
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=8 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Achievement of an HCV RNA Level Below the Limit of Quantification Over Time
|
57.1 percentage of participants
|
83.3 percentage of participants
|
66.7 percentage of participants
|
60.0 percentage of participants
|
83.3 percentage of participants
|
85.7 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
28.6 percentage of participants
|
28.6 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: from day 1 and up to 4 weeksPopulation: FAS
Achievement of a \>= 2 log10 reduction in plasma HCV RNA level from baseline over time.
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=8 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
0.0 percentage of participants
|
83.3 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: from day 1 and up to 4 weeksPopulation: TS
Occurrence of AEs, by action taken with regard to study medication.
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=8 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Occurrence of AEs, by Action Taken With Regard to Study Medication
Action taken: decreasing dose
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
6.7 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Occurrence of AEs, by Action Taken With Regard to Study Medication
Action taken: stop trial medication
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
28.6 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: from day 1 and up to 4 weeksPopulation: TS
Occurrence of discontinuations due to AEs during BI201335 or BI201335+PegIFN/RBV combination treatment period.
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=8 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period
|
0.0 percentage of participants discontinued
|
0.0 percentage of participants discontinued
|
0.0 percentage of participants discontinued
|
0.0 percentage of participants discontinued
|
0.0 percentage of participants discontinued
|
28.6 percentage of participants discontinued
|
0.0 percentage of participants discontinued
|
0.0 percentage of participants discontinued
|
0.0 percentage of participants discontinued
|
0.0 percentage of participants discontinued
|
0.0 percentage of participants discontinued
|
0.0 percentage of participants discontinued
|
SECONDARY outcome
Timeframe: Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)Population: TS
PK (pharmacokinetic) parameter after the first dose: Cmax ( Maximum measured concentration of the analyte in plasma ). .
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=6 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=6 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=7 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=6 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK (Pharmacokinetic) Parameter After the First Dose: Cmax ( Maximum Measured Concentration of the Analyte in Plasma)
|
2360 ng/mL
Geometric Coefficient of Variation 48.3
|
7220 ng/mL
Geometric Coefficient of Variation 48.8
|
7110 ng/mL
Geometric Coefficient of Variation 86.8
|
5970 ng/mL
Geometric Coefficient of Variation 162
|
7660 ng/mL
Geometric Coefficient of Variation 68.1
|
—
|
45.3 ng/mL
Geometric Coefficient of Variation 53.9
|
170 ng/mL
Geometric Coefficient of Variation 21.3
|
964 ng/mL
Geometric Coefficient of Variation 66.1
|
2910 ng/mL
Geometric Coefficient of Variation 51.6
|
164 ng/mL
Geometric Coefficient of Variation 58.1
|
954 ng/mL
Geometric Coefficient of Variation 30.5
|
SECONDARY outcome
Timeframe: Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)Population: TS
PK parameter after the first dose: tmax (Time from (last) dosing to the maximum measured concentration of the analyte in plasma).
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=6 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=6 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=7 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=6 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)
|
3.23 h
Geometric Coefficient of Variation 27.9
|
5.24 h
Geometric Coefficient of Variation 49.2
|
5.30 h
Geometric Coefficient of Variation 34.6
|
6.61 h
Geometric Coefficient of Variation 14.9
|
5.63 h
Geometric Coefficient of Variation 87.4
|
—
|
7.07 h
Geometric Coefficient of Variation 29.0
|
2.48 h
Geometric Coefficient of Variation 149
|
2.12 h
Geometric Coefficient of Variation 56.6
|
3.89 h
Geometric Coefficient of Variation 44.1
|
3.89 h
Geometric Coefficient of Variation 162
|
2.25 h
Geometric Coefficient of Variation 59.1
|
SECONDARY outcome
Timeframe: Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)Population: TS
PK parameter after the first dose: AUCτ,1 (Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ on day 1).
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=6 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=7 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=6 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=7 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=6 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)
|
27700 ng*h/mL
Geometric Coefficient of Variation 59.9
|
108000 ng*h/mL
Geometric Coefficient of Variation 55.5
|
52800 ng*h/mL
Geometric Coefficient of Variation 82.6
|
78400 ng*h/mL
Geometric Coefficient of Variation 157
|
56800 ng*h/mL
Geometric Coefficient of Variation 55.7
|
—
|
736 ng*h/mL
Geometric Coefficient of Variation 57.0
|
2650 ng*h/mL
Geometric Coefficient of Variation 16.5
|
11600 ng*h/mL
Geometric Coefficient of Variation 52.9
|
35700 ng*h/mL
Geometric Coefficient of Variation 48.2
|
2550 ng*h/mL
Geometric Coefficient of Variation 48.3
|
12300 ng*h/mL
Geometric Coefficient of Variation 47.5
|
SECONDARY outcome
Timeframe: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)Population: TS including patients with available Cmax,ss data
PK parameter at steady state after the last dose: Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ).
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=6 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=5 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=6 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=7 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=6 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=6 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter at Steady State After the Last Dose: Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)
|
15400 ng/mL
Geometric Coefficient of Variation 59.8
|
17700 ng/mL
Geometric Coefficient of Variation 81.7
|
32200 ng/mL
Geometric Coefficient of Variation 74.1
|
16400 ng/mL
Geometric Coefficient of Variation 98.3
|
60400 ng/mL
Geometric Coefficient of Variation 55.8
|
—
|
150 ng/mL
Geometric Coefficient of Variation 52.1
|
616 ng/mL
Geometric Coefficient of Variation 62.4
|
4050 ng/mL
Geometric Coefficient of Variation 43.3
|
15400 ng/mL
Geometric Coefficient of Variation 40.4
|
478 ng/mL
Geometric Coefficient of Variation 19.3
|
4170 ng/mL
Geometric Coefficient of Variation 71.7
|
SECONDARY outcome
Timeframe: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)Population: TS including patients with available tmax,ss data
PK parameter at steady state after the last dose: tmax,ss (Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state ).
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=6 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=5 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=6 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=7 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=6 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=6 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter at Steady State After the Last Dose: Tmax,ss (Time From Last Dosing to the Maximum Measured Concentration of the Analyte in Plasma at Steady State )
|
1.99 h
Geometric Coefficient of Variation 46.7
|
3.23 h
Geometric Coefficient of Variation 59.3
|
14.6 h
Geometric Coefficient of Variation 14.1
|
4.12 h
Geometric Coefficient of Variation 53.1
|
17.4 h
Geometric Coefficient of Variation 18.2
|
—
|
4.89 h
Geometric Coefficient of Variation 52.0
|
3.38 h
Geometric Coefficient of Variation 109
|
2.75 h
Geometric Coefficient of Variation 27.6
|
3.36 h
Geometric Coefficient of Variation 67.5
|
2.15 h
Geometric Coefficient of Variation 45.5
|
1.94 h
Geometric Coefficient of Variation 33.6
|
SECONDARY outcome
Timeframe: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)Population: TS including patients with available Cmin,ss data
PK parameter at steady state after the last dose: Cmin,ss (Minimum measured concentration of the analyte in plasma).
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=6 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=5 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=6 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=7 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=6 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=6 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter at Steady State After the Last Dose: Cmin,ss (Minimum Measured Concentration of the Analyte in Plasma)
|
3640 ng/mL
Geometric Coefficient of Variation 105
|
4970 ng/mL
Geometric Coefficient of Variation 124
|
25500 ng/mL
Geometric Coefficient of Variation 80.4
|
5870 ng/mL
Geometric Coefficient of Variation 94.0
|
45400 ng/mL
Geometric Coefficient of Variation 43.1
|
—
|
68.0 ng/mL
Geometric Coefficient of Variation 52.4
|
199 ng/mL
Geometric Coefficient of Variation 64.0
|
1120 ng/mL
Geometric Coefficient of Variation 42.5
|
4040 ng/mL
Geometric Coefficient of Variation 23.3
|
147 ng/mL
Geometric Coefficient of Variation 43.6
|
863 ng/mL
Geometric Coefficient of Variation 88.3
|
SECONDARY outcome
Timeframe: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)Population: TS including patients with available AUCτ,ss data
PK parameter at steady state after the last dose: AUCτ,ss ((Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ).
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=6 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=5 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=6 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=7 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=6 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter at Steady State After the Last Dose: AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)
|
164000 ng*h/mL
Geometric Coefficient of Variation 83.8
|
221000 ng*h/mL
Geometric Coefficient of Variation 82.2
|
350000 ng*h/mL
Geometric Coefficient of Variation 75.6
|
243000 ng*h/mL
Geometric Coefficient of Variation 75.8
|
642000 ng*h/mL
Geometric Coefficient of Variation 46.1
|
—
|
2460 ng*h/mL
Geometric Coefficient of Variation 53.9
|
8520 ng*h/mL
Geometric Coefficient of Variation 55.6
|
49400 ng*h/mL
Geometric Coefficient of Variation 42.8
|
185000 ng*h/mL
Geometric Coefficient of Variation 21.1
|
6820 ng*h/mL
Geometric Coefficient of Variation 22.1
|
43400 ng*h/mL
Geometric Coefficient of Variation 75.9
|
SECONDARY outcome
Timeframe: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)Population: TS including patients with available t1/2,ss data
PK parameter at steady state after the last dose: t1/2,ss (Terminal half-life of the analyte in plasma at steady state \[h\] )
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=6 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=5 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=6 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=7 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=6 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=6 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter at Steady State After the Last Dose: t1/2,ss (Terminal Half-life of the Analyte in Plasma at Steady State )
|
22.1 h
Geometric Coefficient of Variation 27.3
|
19.9 h
Geometric Coefficient of Variation 25.0
|
27.3 h
Geometric Coefficient of Variation 61.5
|
22.7 h
Geometric Coefficient of Variation 33.0
|
41.5 h
Geometric Coefficient of Variation 63.4
|
—
|
30.5 h
Geometric Coefficient of Variation 17.0
|
38.8 h
Geometric Coefficient of Variation 41.2
|
25.5 h
Geometric Coefficient of Variation 25.5
|
19.3 h
Geometric Coefficient of Variation 12.4
|
33.2 h
Geometric Coefficient of Variation 8.58
|
22.5 h
Geometric Coefficient of Variation 17.4
|
SECONDARY outcome
Timeframe: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)Population: TS including patients with available MRTpo,ss data
PK parameter at steady state after the last dose: MRTpo,ss (Mean residence time of the analyte in the body at steady state after oral administration \[h\] )
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=6 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=5 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=6 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=7 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=6 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=6 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter at Steady State After the Last Dose: MRTpo,ss (Mean Residence Time of the Analyte in the Body at Steady State After Oral Administration)
|
27.2 h
Geometric Coefficient of Variation 37.4
|
30.7 h
Geometric Coefficient of Variation 32.5
|
50.5 h
Geometric Coefficient of Variation 59.9
|
34.2 h
Geometric Coefficient of Variation 34.9
|
82.0 h
Geometric Coefficient of Variation 71.6
|
—
|
44.4 h
Geometric Coefficient of Variation 17.0
|
60.2 h
Geometric Coefficient of Variation 61.9
|
33.3 h
Geometric Coefficient of Variation 23.5
|
26.7 h
Geometric Coefficient of Variation 19.3
|
39.7 h
Geometric Coefficient of Variation 14.0
|
26.6 h
Geometric Coefficient of Variation 22.0
|
SECONDARY outcome
Timeframe: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)Population: TS including patients with available CL/F,ss data
PK parameter at steady state after the last dose (if applicable): CL/F,ss (ss Apparent clearance of the analyte in plasma at steady state following multiple oral dose administration \[mL/min\] )
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=6 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=5 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=6 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=7 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=6 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=6 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter at Steady State After the Last Dose: CL/F,ss (Apparent Clearance of the Analyte in Plasma at Steady State Following Multiple Oral Dose Administration )
|
24.4 mL/min
Geometric Coefficient of Variation 83.8
|
18.1 mL/min
Geometric Coefficient of Variation 82.2
|
11.4 mL/min
Geometric Coefficient of Variation 75.6
|
16.4 mL/min
Geometric Coefficient of Variation 75.8
|
6.23 mL/min
Geometric Coefficient of Variation 46.1
|
—
|
136 mL/min
Geometric Coefficient of Variation 53.9
|
93.9 mL/min
Geometric Coefficient of Variation 55.6
|
40.4 mL/min
Geometric Coefficient of Variation 42.8
|
21.6 mL/min
Geometric Coefficient of Variation 21.1
|
117 mL/min
Geometric Coefficient of Variation 22.1
|
46.1 mL/min
Geometric Coefficient of Variation 75.9
|
SECONDARY outcome
Timeframe: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)Population: TS including patients with available Vz/F,ss data
PK parameter at steady state after the last dose: Vz/F,ss (Apparent volume of distribution during the terminal phase z at steady state following an oral administration \[L\] )
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=6 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=5 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=6 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=7 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=6 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=6 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter at Steady State After the Last Dose: Vz/F,ss (Apparent Volume of Distribution During the Terminal Phase z at Steady State Following an Oral Administration )
|
46.7 L
Geometric Coefficient of Variation 65.3
|
31.0 L
Geometric Coefficient of Variation 67.4
|
27.0 L
Geometric Coefficient of Variation 54.4
|
32.3 L
Geometric Coefficient of Variation 40.0
|
22.4 L
Geometric Coefficient of Variation 27.1
|
—
|
358 L
Geometric Coefficient of Variation 46.7
|
315 L
Geometric Coefficient of Variation 69.0
|
89.4 L
Geometric Coefficient of Variation 34.1
|
36.1 L
Geometric Coefficient of Variation 17.9
|
337 L
Geometric Coefficient of Variation 26.7
|
89.9 L
Geometric Coefficient of Variation 80.4
|
SECONDARY outcome
Timeframe: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)Population: TS (for TN patients only)
PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): AUCτ,ss ( Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ ).
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=6 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=7 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=6 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=6 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ )
|
—
|
—
|
—
|
—
|
—
|
—
|
1970 ng*h/mL
Geometric Coefficient of Variation 46.5
|
8740 ng*h/mL
Geometric Coefficient of Variation 52.1
|
45800 ng*h/mL
Geometric Coefficient of Variation 85.4
|
180000 ng*h/mL
Geometric Coefficient of Variation 42.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)Population: TS (for TN patients only)
PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmax,ss.
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=6 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=7 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=6 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=6 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmax,ss
|
—
|
—
|
—
|
—
|
—
|
—
|
106 ng/mL
Geometric Coefficient of Variation 47.5
|
693 ng/mL
Geometric Coefficient of Variation 61.1
|
3880 ng/mL
Geometric Coefficient of Variation 82.8
|
13100 ng/mL
Geometric Coefficient of Variation 38.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)Population: TS (for TN patients only)
PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmin, ss.
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=6 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=7 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=6 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=6 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmin, ss
|
—
|
—
|
—
|
—
|
—
|
—
|
57.8 ng/mL
Geometric Coefficient of Variation 46.2
|
185 ng/mL
Geometric Coefficient of Variation 64.8
|
1010 ng/mL
Geometric Coefficient of Variation 97.9
|
4320 ng/mL
Geometric Coefficient of Variation 42.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 14, and Day 28Population: TS including patients with available RAcmax data
For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=6 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=5 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=6 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=7 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=6 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=6 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax
|
6.53 ratio
Geometric Coefficient of Variation 75.7
|
2.45 ratio
Geometric Coefficient of Variation 89.4
|
4.53 ratio
Geometric Coefficient of Variation 96.0
|
2.74 ratio
Geometric Coefficient of Variation 90.5
|
6.81 ratio
Geometric Coefficient of Variation 154
|
—
|
2.34 ratio
Geometric Coefficient of Variation 29.1
|
4.08 ratio
Geometric Coefficient of Variation 66.6
|
3.74 ratio
Geometric Coefficient of Variation 32.5
|
4.49 ratio
Geometric Coefficient of Variation 36.2
|
2.91 ratio
Geometric Coefficient of Variation 58.7
|
4.37 ratio
Geometric Coefficient of Variation 50.6
|
SECONDARY outcome
Timeframe: Day 1, Day 14, and Day 28Population: TS including patients with available RAauc data
For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.
Outcome measures
| Measure |
TE Non-cirrhotic: 120 mg QD
n=6 Participants
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 Participants
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=6 Participants
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=5 Participants
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: Placebo
n=6 Participants
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
|
Treatment Naive(TN): 20mg QD
n=7 Participants
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=6 Participants
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=6 Participants
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 Participants
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=7 Participants
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc
|
5.90 ratio
Geometric Coefficient of Variation 56.6
|
2.05 ratio
Geometric Coefficient of Variation 88.8
|
6.62 ratio
Geometric Coefficient of Variation 88.8
|
3.11 ratio
Geometric Coefficient of Variation 96.6
|
10.0 ratio
Geometric Coefficient of Variation 111
|
—
|
2.68 ratio
Geometric Coefficient of Variation 19.6
|
3.30 ratio
Geometric Coefficient of Variation 49.9
|
3.61 ratio
Geometric Coefficient of Variation 42.0
|
5.03 ratio
Geometric Coefficient of Variation 45.3
|
2.68 ratio
Geometric Coefficient of Variation 36.2
|
3.52 ratio
Geometric Coefficient of Variation 34.0
|
Adverse Events
Treatment Naive (TN): Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment Naive(TN): 20mg QD
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
TN: 48mg QD
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
TN: 120mg QD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
TN: 240mg QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
TE Non-cirrhotic: 120 mg QD
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
TE Non-cirrhotic: 240 mg QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
TE Non-cirrhotic: 240 mg BID SGC
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
TE With Cirrhosis: 240 mg QD SGC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
TE With Cirrhosis: 240 mg BID SGC
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Naive (TN): Placebo
n=8 participants at risk
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 participants at risk
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 participants at risk
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 participants at risk
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 participants at risk
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 participants at risk
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 120 mg QD
n=7 participants at risk
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 participants at risk
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 participants at risk
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 participants at risk
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 participants at risk
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 participants at risk
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Asthenia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
Other adverse events
| Measure |
Treatment Naive (TN): Placebo
n=8 participants at risk
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
|
Treatment Naive(TN): 20mg QD
n=6 participants at risk
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
|
TN: 48mg QD
n=7 participants at risk
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 120mg QD
n=7 participants at risk
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TN: 240mg QD
n=6 participants at risk
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
|
Treatment Experienced (TE) Non-cirrhotic: 48 mg QD
n=6 participants at risk
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 120 mg QD
n=7 participants at risk
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD
n=6 participants at risk
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
n=15 participants at risk
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE Non-cirrhotic: 240 mg BID SGC
n=15 participants at risk
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg QD SGC
n=6 participants at risk
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
TE With Cirrhosis: 240 mg BID SGC
n=7 participants at risk
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Tooth abscess
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
20.0%
3/15 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Eye disorders
Dry eye
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Eye disorders
Eyelids pruritus
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Eye disorders
Ocular icterus
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Eye disorders
Photophobia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Eye disorders
Vision blurred
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Eye disorders
Visual impairment
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Colitis
|
12.5%
1/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
50.0%
3/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
53.3%
8/15 • day 1 and up to 4 weeks + washout
|
33.3%
5/15 • day 1 and up to 4 weeks + washout
|
66.7%
4/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Faeces discoloured
|
12.5%
1/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
1/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
42.9%
3/7 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
42.9%
3/7 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
53.3%
8/15 • day 1 and up to 4 weeks + washout
|
53.3%
8/15 • day 1 and up to 4 weeks + washout
|
66.7%
4/6 • day 1 and up to 4 weeks + washout
|
85.7%
6/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
40.0%
6/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
71.4%
5/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Asthenia
|
25.0%
2/8 • day 1 and up to 4 weeks + washout
|
50.0%
3/6 • day 1 and up to 4 weeks + washout
|
42.9%
3/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
66.7%
4/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
20.0%
3/15 • day 1 and up to 4 weeks + washout
|
33.3%
5/15 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
57.1%
4/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Chest pain
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Chills
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
26.7%
4/15 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
66.7%
4/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Fatigue
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
50.0%
3/6 • day 1 and up to 4 weeks + washout
|
73.3%
11/15 • day 1 and up to 4 weeks + washout
|
20.0%
3/15 • day 1 and up to 4 weeks + washout
|
50.0%
3/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Feeling abnormal
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Feeling cold
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Hyperthermia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
50.0%
3/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
42.9%
3/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Injection site erythema
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
50.0%
3/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Injection site pruritus
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Injection site rash
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Injection site reaction
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Irritability
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
42.9%
3/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Mucosal dryness
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Mucosal ulceration
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Oedema peripheral
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Pain
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
General disorders
Pyrexia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
66.7%
4/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
40.0%
6/15 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Infections and infestations
Influenza
|
25.0%
2/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
42.9%
3/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Infections and infestations
Oral herpes
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Infections and infestations
Rhinitis
|
12.5%
1/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Investigations
Body temperature increased
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Investigations
Cardiac murmur
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Investigations
Weight decreased
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
2/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
50.0%
3/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
42.9%
3/7 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
20.0%
3/15 • day 1 and up to 4 weeks + washout
|
66.7%
4/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Nervous system disorders
Amnesia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
42.9%
3/7 • day 1 and up to 4 weeks + washout
|
50.0%
3/6 • day 1 and up to 4 weeks + washout
|
60.0%
9/15 • day 1 and up to 4 weeks + washout
|
66.7%
10/15 • day 1 and up to 4 weeks + washout
|
66.7%
4/6 • day 1 and up to 4 weeks + washout
|
42.9%
3/7 • day 1 and up to 4 weeks + washout
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Nervous system disorders
Migraine
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Psychiatric disorders
Aggression
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Psychiatric disorders
Agitation
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Psychiatric disorders
Depression
|
12.5%
1/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
33.3%
5/15 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
50.0%
3/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
20.0%
3/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
13.3%
2/15 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
|
Respiratory, thoracic and mediastinal disorders
Larynx irritation
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
50.0%
3/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
20.0%
3/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
28.6%
2/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
42.9%
3/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Photosensitivity allergic reaction
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
50.0%
3/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
26.7%
4/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
50.0%
3/6 • day 1 and up to 4 weeks + washout
|
42.9%
3/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
33.3%
2/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
16.7%
1/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
|
Surgical and medical procedures
Dental implantation
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Vascular disorders
Haematoma
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Vascular disorders
Hot flush
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
14.3%
1/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/15 • day 1 and up to 4 weeks + washout
|
6.7%
1/15 • day 1 and up to 4 weeks + washout
|
0.00%
0/6 • day 1 and up to 4 weeks + washout
|
0.00%
0/7 • day 1 and up to 4 weeks + washout
|
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