Trial Outcomes & Findings for A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment (NCT NCT00980330)
NCT ID: NCT00980330
Last Updated: 2014-06-09
Results Overview
The table below shows the percentage of participants in the overall population with an SVR24, defined as having plasma levels of Hepatitis C Virus ribonucleic acid less than 25 IU/mL undetectable at the EOT and 24 weeks after the EOT.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
463 participants
Primary outcome timeframe
Week 72
Results posted on
2014-06-09
Participant Flow
The study was conducted at 89 sites in 14 countries.
A total of 618 participants were screened. Of these, 463 participants were randomized of whom 462 participants started treatment. One participant in the placebo group was 'randomized in error,' did not receive treatment, and was withdrawn from the study due to non-compliance (did not come for visit).
Participant milestones
| Measure |
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
66
|
65
|
66
|
66
|
68
|
65
|
66
|
|
Overall Study
COMPLETED
|
61
|
60
|
58
|
61
|
63
|
61
|
59
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
8
|
5
|
5
|
4
|
7
|
Reasons for withdrawal
| Measure |
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
4
|
2
|
1
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
4
|
1
|
3
|
2
|
5
|
|
Overall Study
(not specified)
|
2
|
0
|
0
|
1
|
1
|
1
|
0
|
Baseline Characteristics
A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment
Baseline characteristics by cohort
| Measure |
TMC435 100mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
n=65 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
n=68 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
TMC435 150mg 48 Wks + PR48
n=65 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
n=66 Participants
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Total
n=462 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.5 years
n=5 Participants
|
50 years
n=7 Participants
|
50 years
n=5 Participants
|
48 years
n=4 Participants
|
51.5 years
n=21 Participants
|
50 years
n=8 Participants
|
50.5 years
n=8 Participants
|
50 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
151 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
48 Participants
n=8 Participants
|
42 Participants
n=8 Participants
|
311 Participants
n=24 Participants
|
|
Region of Enrollment
Asia Pacific
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
1 participants
n=21 Participants
|
4 participants
n=8 Participants
|
7 participants
n=8 Participants
|
29 participants
n=24 Participants
|
|
Region of Enrollment
Europe and Israel
|
34 participants
n=5 Participants
|
46 participants
n=7 Participants
|
46 participants
n=5 Participants
|
49 participants
n=4 Participants
|
49 participants
n=21 Participants
|
43 participants
n=8 Participants
|
46 participants
n=8 Participants
|
313 participants
n=24 Participants
|
|
Region of Enrollment
North-America
|
28 participants
n=5 Participants
|
14 participants
n=7 Participants
|
16 participants
n=5 Participants
|
13 participants
n=4 Participants
|
18 participants
n=21 Participants
|
18 participants
n=8 Participants
|
13 participants
n=8 Participants
|
120 participants
n=24 Participants
|
|
Prior PR response
Null responder
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
18 participants
n=5 Participants
|
17 participants
n=4 Participants
|
17 participants
n=21 Participants
|
17 participants
n=8 Participants
|
16 participants
n=8 Participants
|
117 participants
n=24 Participants
|
|
Prior PR response
Partial responder
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
22 participants
n=5 Participants
|
23 participants
n=4 Participants
|
24 participants
n=21 Participants
|
22 participants
n=8 Participants
|
23 participants
n=8 Participants
|
160 participants
n=24 Participants
|
|
Prior PR response
Relapser
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
26 participants
n=5 Participants
|
26 participants
n=4 Participants
|
27 participants
n=21 Participants
|
26 participants
n=8 Participants
|
27 participants
n=8 Participants
|
185 participants
n=24 Participants
|
|
Metavir Score
Not reported
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
2 participants
n=8 Participants
|
7 participants
n=24 Participants
|
|
Metavir Score
Score F0
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
11 participants
n=21 Participants
|
1 participants
n=8 Participants
|
7 participants
n=8 Participants
|
39 participants
n=24 Participants
|
|
Metavir Score
Score F1
|
17 participants
n=5 Participants
|
14 participants
n=7 Participants
|
23 participants
n=5 Participants
|
19 participants
n=4 Participants
|
11 participants
n=21 Participants
|
27 participants
n=8 Participants
|
18 participants
n=8 Participants
|
129 participants
n=24 Participants
|
|
Metavir Score
Score F2
|
21 participants
n=5 Participants
|
17 participants
n=7 Participants
|
9 participants
n=5 Participants
|
18 participants
n=4 Participants
|
21 participants
n=21 Participants
|
16 participants
n=8 Participants
|
16 participants
n=8 Participants
|
118 participants
n=24 Participants
|
|
Metavir Score
Score F3
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
14 participants
n=5 Participants
|
11 participants
n=4 Participants
|
11 participants
n=21 Participants
|
7 participants
n=8 Participants
|
13 participants
n=8 Participants
|
86 participants
n=24 Participants
|
|
Metavir Score
Score F4
|
7 participants
n=5 Participants
|
13 participants
n=7 Participants
|
14 participants
n=5 Participants
|
13 participants
n=4 Participants
|
13 participants
n=21 Participants
|
13 participants
n=8 Participants
|
10 participants
n=8 Participants
|
83 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Week 72Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.
The table below shows the percentage of participants in the overall population with an SVR24, defined as having plasma levels of Hepatitis C Virus ribonucleic acid less than 25 IU/mL undetectable at the EOT and 24 weeks after the EOT.
Outcome measures
| Measure |
TMC435 150mg 48 Wks + PR48
n=65 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
n=66 Participants
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 100mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
n=65 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
n=68 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)
|
80.0 Percentage of participants
|
22.7 Percentage of participants
|
69.7 Percentage of participants
|
66.2 Percentage of participants
|
60.6 Percentage of participants
|
66.7 Percentage of participants
|
72.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Weeks, 2, 4, 8, and 12Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.
The table below shows the percentage of participants in each treatment group who achieved a greater than 2 log10 drop in plasma levels of HCV RNA at selected time points during treatment.
Outcome measures
| Measure |
TMC435 150mg 48 Wks + PR48
n=65 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
n=66 Participants
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 100mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
n=65 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
n=68 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During Treatment
Week 2
|
96.9 Percentage of participants
|
24.2 Percentage of participants
|
97.0 Percentage of participants
|
93.8 Percentage of participants
|
97.0 Percentage of participants
|
100.0 Percentage of participants
|
95.6 Percentage of participants
|
|
The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During Treatment
Week 4
|
96.9 Percentage of participants
|
36.4 Percentage of participants
|
92.4 Percentage of participants
|
93.8 Percentage of participants
|
92.4 Percentage of participants
|
97.0 Percentage of participants
|
91.2 Percentage of participants
|
|
The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During Treatment
Week 8
|
95.4 Percentage of participants
|
57.6 Percentage of participants
|
92.4 Percentage of participants
|
89.2 Percentage of participants
|
89.4 Percentage of participants
|
93.9 Percentage of participants
|
91.2 Percentage of participants
|
|
The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During Treatment
Week 12
|
92.3 Percentage of participants
|
60.6 Percentage of participants
|
90.9 Percentage of participants
|
87.7 Percentage of participants
|
84.8 Percentage of participants
|
92.4 Percentage of participants
|
91.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72 and EOT (up to Week 48)Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.
The table below shows the percentage of participants in each treatment who achieved plasma HCV RNA levels of \<25 IU/mL undetectable at selected time points during treatment and follow-up and at the end of treatment (EOT).
Outcome measures
| Measure |
TMC435 150mg 48 Wks + PR48
n=65 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
n=66 Participants
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 100mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
n=65 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
n=68 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up
Week 2
|
27.7 Percentage of participants
|
0.0 Percentage of participants
|
22.7 Percentage of participants
|
18.5 Percentage of participants
|
15.2 Percentage of participants
|
24.2 Percentage of participants
|
32.4 Percentage of participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up
Week 4
|
66.2 Percentage of participants
|
1.5 Percentage of participants
|
66.7 Percentage of participants
|
58.5 Percentage of participants
|
53.0 Percentage of participants
|
62.1 Percentage of participants
|
67.6 Percentage of participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up
Week 8
|
83.1 Percentage of participants
|
7.6 Percentage of participants
|
77.3 Percentage of participants
|
75.4 Percentage of participants
|
77.3 Percentage of participants
|
84.8 Percentage of participants
|
83.8 Percentage of participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up
Week 12
|
83.1 Percentage of participants
|
19.7 Percentage of participants
|
81.8 Percentage of participants
|
73.8 Percentage of participants
|
72.7 Percentage of participants
|
80.3 Percentage of participants
|
85.3 Percentage of participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up
Week 24
|
86.2 Percentage of participants
|
42.4 Percentage of participants
|
81.8 Percentage of participants
|
75.4 Percentage of participants
|
78.8 Percentage of participants
|
83.3 Percentage of participants
|
86.8 Percentage of participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up
Week 36
|
81.5 Percentage of participants
|
39.4 Percentage of participants
|
78.8 Percentage of participants
|
73.8 Percentage of participants
|
78.8 Percentage of participants
|
80.3 Percentage of participants
|
83.8 Percentage of participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up
Week 48
|
81.5 Percentage of participants
|
37.9 Percentage of participants
|
81.8 Percentage of participants
|
73.8 Percentage of participants
|
74.2 Percentage of participants
|
75.8 Percentage of participants
|
80.9 Percentage of participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up
Week 60
|
76.9 Percentage of participants
|
22.7 Percentage of participants
|
69.7 Percentage of participants
|
67.7 Percentage of participants
|
59.1 Percentage of participants
|
66.7 Percentage of participants
|
72.1 Percentage of participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up
Week 72
|
80.0 Percentage of participants
|
22.7 Percentage of participants
|
69.7 Percentage of participants
|
66.2 Percentage of participants
|
60.6 Percentage of participants
|
66.7 Percentage of participants
|
73.5 Percentage of participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up
EOT (up to Week 48)
|
86.2 Percentage of participants
|
40.9 Percentage of participants
|
80.3 Percentage of participants
|
78.5 Percentage of participants
|
80.3 Percentage of participants
|
80.3 Percentage of participants
|
83.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and EOT (up to Week 48)Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.
The table below shows the percentage of participants in each treatment group who achieved plasma HCV RNA levels below the limit of quantification defined as less than 25 IU/mL (detectable or undetectable) at selected time points during treatment, follow-up, and at the end of treatment (EOT).
Outcome measures
| Measure |
TMC435 150mg 48 Wks + PR48
n=65 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
n=66 Participants
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 100mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
n=65 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
n=68 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up
Week 2
|
66.2 Percentage of Participants
|
3.0 Percentage of Participants
|
60.6 Percentage of Participants
|
55.4 Percentage of Participants
|
54.5 Percentage of Participants
|
63.6 Percentage of Participants
|
60.3 Percentage of Participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up
Week 4
|
86.2 Percentage of Participants
|
3.0 Percentage of Participants
|
78.8 Percentage of Participants
|
72.3 Percentage of Participants
|
81.8 Percentage of Participants
|
86.4 Percentage of Participants
|
82.4 Percentage of Participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up
Week 8
|
87.7 Percentage of Participants
|
12.1 Percentage of Participants
|
87.9 Percentage of Participants
|
81.5 Percentage of Participants
|
84.8 Percentage of Participants
|
87.9 Percentage of Participants
|
89.7 Percentage of Participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up
Week 12
|
89.2 Percentage of Participants
|
34.8 Percentage of Participants
|
87.9 Percentage of Participants
|
81.5 Percentage of Participants
|
83.3 Percentage of Participants
|
89.4 Percentage of Participants
|
88.2 Percentage of Participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up
Week 24
|
89.2 Percentage of Participants
|
50.0 Percentage of Participants
|
84.8 Percentage of Participants
|
78.5 Percentage of Participants
|
80.3 Percentage of Participants
|
86.4 Percentage of Participants
|
86.8 Percentage of Participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up
Week 36
|
84.6 Percentage of Participants
|
43.9 Percentage of Participants
|
81.8 Percentage of Participants
|
73.8 Percentage of Participants
|
78.8 Percentage of Participants
|
81.8 Percentage of Participants
|
86.8 Percentage of Participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up
Week 48
|
81.5 Percentage of Participants
|
40.9 Percentage of Participants
|
83.3 Percentage of Participants
|
73.8 Percentage of Participants
|
74.2 Percentage of Participants
|
78.8 Percentage of Participants
|
82.4 Percentage of Participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up
Week 60
|
78.5 Percentage of Participants
|
22.7 Percentage of Participants
|
71.2 Percentage of Participants
|
67.7 Percentage of Participants
|
60.6 Percentage of Participants
|
66.7 Percentage of Participants
|
72.1 Percentage of Participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up
Week 72
|
80.0 Percentage of Participants
|
22.7 Percentage of Participants
|
69.7 Percentage of Participants
|
66.2 Percentage of Participants
|
60.6 Percentage of Participants
|
66.7 Percentage of Participants
|
73.5 Percentage of Participants
|
|
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up
EOT (up to Week 48)
|
89.2 Percentage of Participants
|
47.0 Percentage of Participants
|
86.4 Percentage of Participants
|
81.5 Percentage of Participants
|
81.8 Percentage of Participants
|
89.4 Percentage of Participants
|
89.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 4Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.
The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having an undetectable plasma Hepatitis C virus ribonucleic acid level after receiving 4 weeks of treatment.
Outcome measures
| Measure |
TMC435 150mg 48 Wks + PR48
n=65 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
n=66 Participants
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 100mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
n=65 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
n=68 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving a Rapid Virologic Response (RVR)
|
66.2 Percentage of participants
|
1.5 Percentage of participants
|
66.7 Percentage of participants
|
58.5 Percentage of participants
|
53.0 Percentage of participants
|
62.1 Percentage of participants
|
67.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.
The table below shows the percentage of participants who achieved an EVR, defined as having a greater than or equal to 2 log10 reduction in plasma Hepatitis C virus ribonucleic acid from baseline at Week 12.
Outcome measures
| Measure |
TMC435 150mg 48 Wks + PR48
n=65 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
n=66 Participants
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 100mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
n=65 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
n=68 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving an Early Virologic Response (EVR)
|
92.3 Percentage of participants
|
60.6 Percentage of participants
|
90.9 Percentage of participants
|
87.7 Percentage of participants
|
84.8 Percentage of participants
|
92.4 Percentage of participants
|
91.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.
The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma levels of Hepatitis C virus ribonucleic acid at Week 12.
Outcome measures
| Measure |
TMC435 150mg 48 Wks + PR48
n=65 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
n=66 Participants
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 100mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
n=65 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
n=68 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)
|
83.1 Percentage of participants
|
19.7 Percentage of participants
|
81.8 Percentage of participants
|
73.8 Percentage of participants
|
72.7 Percentage of participants
|
80.3 Percentage of participants
|
85.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 60Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.
The table below shows the percentage of participants in the overall population who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the planned EOT.
Outcome measures
| Measure |
TMC435 150mg 48 Wks + PR48
n=65 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
n=66 Participants
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 100mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
n=65 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
n=68 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
|
80.0 Percentage of participants
|
22.7 Percentage of participants
|
69.7 Percentage of participants
|
67.7 Percentage of participants
|
60.6 Percentage of participants
|
66.7 Percentage of participants
|
72.1 Percentage of participants
|
SECONDARY outcome
Timeframe: EOT (up to Week 48)Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.
The table below shows the percentage of participants in the overall population in each treatment group during the treatment period who experienced viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in Hepatitis C virus (HCV) ribonucleic acid (RNA) from the lowest level reached or a confirmed HCV RNA of \> 100 IU/mL in participants whose HCV RNA had previously been below the lower limit of quantification (i.e., less than 25 IU/mL detectable or undetectable).
Outcome measures
| Measure |
TMC435 150mg 48 Wks + PR48
n=65 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
n=66 Participants
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 100mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
n=65 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
n=68 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
The Percentage of Participants With Viral Breakthrough
|
7.7 Percentage of participants
|
1.5 Percentage of participants
|
10.6 Percentage of participants
|
13.8 Percentage of participants
|
13.6 Percentage of participants
|
9.1 Percentage of participants
|
10.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 72Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.
The table below shows the percentage of participants in the overall population who had viral relapse, defined as confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with HCV RNA less than 25 IU/mL undetectable at end of treatment.
Outcome measures
| Measure |
TMC435 150mg 48 Wks + PR48
n=65 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
n=66 Participants
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 100mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
n=65 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
n=68 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
The Percentage of Participants With Viral Relapse
|
5.5 Percentage of participants
|
44.4 Percentage of participants
|
9.3 Percentage of participants
|
13.7 Percentage of participants
|
18.0 Percentage of participants
|
11.8 Percentage of participants
|
14.0 Percentage of participants
|
SECONDARY outcome
Timeframe: EOT (up to Week 48)Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.
The table below shows the number of participants with abnormal ALT levels at Baseline who achieved the normal ALT levels at the EOT (up to Week 48).
Outcome measures
| Measure |
TMC435 150mg 48 Wks + PR48
n=43 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
n=256 Participants
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 100mg 12 Wks + PR48
n=36 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
n=49 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
n=45 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
n=40 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
n=43 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)
|
33 Percentage of participants
|
181 Percentage of participants
|
26 Percentage of participants
|
37 Percentage of participants
|
31 Percentage of participants
|
23 Percentage of participants
|
31 Percentage of participants
|
SECONDARY outcome
Timeframe: 0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48Population: Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.
The table below shows median (range) predose plasma concentration (C0h) values and median (range) average steady-state plasma concentration (Css,av) values for TMC435 for participants in each of the 6 TMC435 treatment groups.
Outcome measures
| Measure |
TMC435 150mg 48 Wks + PR48
n=64 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 100mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
n=65 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
n=65 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
n=68 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Plasma Concentrations of TMC435
Css,av
|
1606.9 ng/mL
Interval 635.0 to 22417.0
|
—
|
691.1 ng/mL
Interval 204.0 to 3960.0
|
770.5 ng/mL
Interval 344.0 to 7218.0
|
892.0 ng/mL
Interval 290.0 to 4580.0
|
1960.9 ng/mL
Interval 304.0 to 13047.0
|
1792.3 ng/mL
Interval 532.0 to 14892.0
|
|
Plasma Concentrations of TMC435
C0h
|
886.1 ng/mL
Interval 150.0 to 21825.0
|
—
|
380.5 ng/mL
Interval 34.0 to 3599.0
|
411.3 ng/mL
Interval 101.0 to 6943.0
|
529.8 ng/mL
Interval 62.0 to 4212.0
|
1323.5 ng/mL
Interval 37.0 to 12478.0
|
1074.0 ng/mL
Interval 110.0 to 14303.0
|
SECONDARY outcome
Timeframe: 0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48Population: Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.
The table below shows the median (range) AUC24h values for TMC435 for participants in each TMC435 treatment group.
Outcome measures
| Measure |
TMC435 150mg 48 Wks + PR48
n=64 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 100mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
n=65 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
n=65 Participants
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
n=66 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
n=68 Participants
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435
|
38564.5 ng.h/mL
Interval 15233.0 to 538010.0
|
—
|
16587.0 ng.h/mL
Interval 4897.0 to 95030.0
|
18492.5 ng.h/mL
Interval 8252.0 to 173240.0
|
21409.0 ng.h/mL
Interval 6949.0 to 109920.0
|
47061.8 ng.h/mL
Interval 7301.0 to 313135.0
|
43015.0 ng.h/mL
Interval 12777.0 to 357415.0
|
Adverse Events
TMC435 100mg 12 Wks + PR48
Serious events: 3 serious events
Other events: 63 other events
Deaths: 0 deaths
TMC435 100mg 24 Wks + PR48
Serious events: 5 serious events
Other events: 61 other events
Deaths: 0 deaths
TMC435 100mg 48 Wks + PR48
Serious events: 3 serious events
Other events: 65 other events
Deaths: 0 deaths
TMC435 150mg 12 Wks + PR48
Serious events: 7 serious events
Other events: 63 other events
Deaths: 0 deaths
TMC435 150mg 24 Wks + PR48
Serious events: 5 serious events
Other events: 65 other events
Deaths: 0 deaths
TMC435 150mg 48 Wks + PR48
Serious events: 8 serious events
Other events: 63 other events
Deaths: 0 deaths
Placebo 48Wks + PR48
Serious events: 4 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TMC435 100mg 12 Wks + PR48
n=66 participants at risk
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
n=65 participants at risk
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
n=66 participants at risk
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
n=66 participants at risk
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
n=68 participants at risk
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
TMC435 150mg 48 Wks + PR48
n=65 participants at risk
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
n=66 participants at risk
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/66 • Week 72
|
3.1%
2/65 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Infections and infestations
Cellulitis
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/68 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/66 • Week 72
|
1.5%
1/65 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Infections and infestations
Gingival infection
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Infections and infestations
Lung infection
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Infections and infestations
Pneumonia
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Infections and infestations
Pneumonia bordetella
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Infections and infestations
Salpingitis
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Infections and infestations
Sinusitis
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
1.5%
1/66 • Week 72
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
1.5%
1/66 • Week 72
|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
1/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/66 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/68 • Week 72
|
0.00%
0/65 • Week 72
|
1.5%
1/66 • Week 72
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/66 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
1.5%
1/66 • Week 72
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
1.5%
1/66 • Week 72
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurilemmoma benign
|
0.00%
0/66 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
1.5%
1/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Histiocytosis haematophagic
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
1.5%
1/66 • Week 72
|
|
Nervous system disorders
Brain injury
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Nervous system disorders
Coma
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Nervous system disorders
Headache
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Nervous system disorders
Migraine
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Nervous system disorders
Viith nerve paralysis
|
0.00%
0/66 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Nervous system disorders
Sciatica
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
1.5%
1/66 • Week 72
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/66 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/66 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
General disorders
Pyrexia
|
0.00%
0/66 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
1/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Injury, poisoning and procedural complications
Overdose
|
1.5%
1/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Psychiatric disorders
Suicide attempt
|
1.5%
1/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/66 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
1.5%
1/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Vascular disorders
Hypertension
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Investigations
Weight decreased
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
1.5%
1/66 • Week 72
|
Other adverse events
| Measure |
TMC435 100mg 12 Wks + PR48
n=66 participants at risk
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
|
TMC435 100mg 24 Wks + PR48
n=65 participants at risk
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
|
TMC435 100mg 48 Wks + PR48
n=66 participants at risk
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
TMC435 150mg 12 Wks + PR48
n=66 participants at risk
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
|
TMC435 150mg 24 Wks + PR48
n=68 participants at risk
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
|
TMC435 150mg 48 Wks + PR48
n=65 participants at risk
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
Placebo 48Wks + PR48
n=66 participants at risk
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/66 • Week 72
|
4.6%
3/65 • Week 72
|
4.5%
3/66 • Week 72
|
4.5%
3/66 • Week 72
|
5.9%
4/68 • Week 72
|
1.5%
1/65 • Week 72
|
7.6%
5/66 • Week 72
|
|
General disorders
Fatigue
|
45.5%
30/66 • Week 72
|
43.1%
28/65 • Week 72
|
51.5%
34/66 • Week 72
|
39.4%
26/66 • Week 72
|
41.2%
28/68 • Week 72
|
43.1%
28/65 • Week 72
|
43.9%
29/66 • Week 72
|
|
General disorders
Influenza like illness
|
34.8%
23/66 • Week 72
|
36.9%
24/65 • Week 72
|
31.8%
21/66 • Week 72
|
24.2%
16/66 • Week 72
|
26.5%
18/68 • Week 72
|
21.5%
14/65 • Week 72
|
19.7%
13/66 • Week 72
|
|
General disorders
Asthenia
|
9.1%
6/66 • Week 72
|
24.6%
16/65 • Week 72
|
16.7%
11/66 • Week 72
|
24.2%
16/66 • Week 72
|
23.5%
16/68 • Week 72
|
29.2%
19/65 • Week 72
|
10.6%
7/66 • Week 72
|
|
General disorders
Pyrexia
|
9.1%
6/66 • Week 72
|
15.4%
10/65 • Week 72
|
19.7%
13/66 • Week 72
|
21.2%
14/66 • Week 72
|
25.0%
17/68 • Week 72
|
13.8%
9/65 • Week 72
|
13.6%
9/66 • Week 72
|
|
General disorders
Irritability
|
13.6%
9/66 • Week 72
|
12.3%
8/65 • Week 72
|
15.2%
10/66 • Week 72
|
12.1%
8/66 • Week 72
|
14.7%
10/68 • Week 72
|
12.3%
8/65 • Week 72
|
10.6%
7/66 • Week 72
|
|
General disorders
Chills
|
10.6%
7/66 • Week 72
|
6.2%
4/65 • Week 72
|
6.1%
4/66 • Week 72
|
9.1%
6/66 • Week 72
|
8.8%
6/68 • Week 72
|
10.8%
7/65 • Week 72
|
9.1%
6/66 • Week 72
|
|
General disorders
Injection site erythema
|
4.5%
3/66 • Week 72
|
6.2%
4/65 • Week 72
|
1.5%
1/66 • Week 72
|
4.5%
3/66 • Week 72
|
4.4%
3/68 • Week 72
|
10.8%
7/65 • Week 72
|
3.0%
2/66 • Week 72
|
|
General disorders
Injection site reaction
|
4.5%
3/66 • Week 72
|
3.1%
2/65 • Week 72
|
6.1%
4/66 • Week 72
|
3.0%
2/66 • Week 72
|
4.4%
3/68 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
General disorders
Pain
|
1.5%
1/66 • Week 72
|
3.1%
2/65 • Week 72
|
1.5%
1/66 • Week 72
|
6.1%
4/66 • Week 72
|
2.9%
2/68 • Week 72
|
4.6%
3/65 • Week 72
|
6.1%
4/66 • Week 72
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.8%
19/66 • Week 72
|
40.0%
26/65 • Week 72
|
31.8%
21/66 • Week 72
|
30.3%
20/66 • Week 72
|
36.8%
25/68 • Week 72
|
36.9%
24/65 • Week 72
|
16.7%
11/66 • Week 72
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.6%
9/66 • Week 72
|
23.1%
15/65 • Week 72
|
18.2%
12/66 • Week 72
|
21.2%
14/66 • Week 72
|
14.7%
10/68 • Week 72
|
18.5%
12/65 • Week 72
|
15.2%
10/66 • Week 72
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.1%
8/66 • Week 72
|
12.3%
8/65 • Week 72
|
9.1%
6/66 • Week 72
|
15.2%
10/66 • Week 72
|
19.1%
13/68 • Week 72
|
24.6%
16/65 • Week 72
|
13.6%
9/66 • Week 72
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.6%
5/66 • Week 72
|
4.6%
3/65 • Week 72
|
10.6%
7/66 • Week 72
|
10.6%
7/66 • Week 72
|
8.8%
6/68 • Week 72
|
10.8%
7/65 • Week 72
|
7.6%
5/66 • Week 72
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.1%
4/66 • Week 72
|
7.7%
5/65 • Week 72
|
10.6%
7/66 • Week 72
|
4.5%
3/66 • Week 72
|
7.4%
5/68 • Week 72
|
3.1%
2/65 • Week 72
|
3.0%
2/66 • Week 72
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.5%
3/66 • Week 72
|
4.6%
3/65 • Week 72
|
7.6%
5/66 • Week 72
|
4.5%
3/66 • Week 72
|
0.00%
0/68 • Week 72
|
1.5%
1/65 • Week 72
|
3.0%
2/66 • Week 72
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/66 • Week 72
|
1.5%
1/65 • Week 72
|
3.0%
2/66 • Week 72
|
1.5%
1/66 • Week 72
|
4.4%
3/68 • Week 72
|
10.8%
7/65 • Week 72
|
1.5%
1/66 • Week 72
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.5%
1/66 • Week 72
|
1.5%
1/65 • Week 72
|
7.6%
5/66 • Week 72
|
1.5%
1/66 • Week 72
|
1.5%
1/68 • Week 72
|
1.5%
1/65 • Week 72
|
4.5%
3/66 • Week 72
|
|
Gastrointestinal disorders
Nausea
|
25.8%
17/66 • Week 72
|
15.4%
10/65 • Week 72
|
30.3%
20/66 • Week 72
|
30.3%
20/66 • Week 72
|
16.2%
11/68 • Week 72
|
26.2%
17/65 • Week 72
|
21.2%
14/66 • Week 72
|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
9/66 • Week 72
|
16.9%
11/65 • Week 72
|
19.7%
13/66 • Week 72
|
13.6%
9/66 • Week 72
|
11.8%
8/68 • Week 72
|
13.8%
9/65 • Week 72
|
19.7%
13/66 • Week 72
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
6/66 • Week 72
|
6.2%
4/65 • Week 72
|
6.1%
4/66 • Week 72
|
4.5%
3/66 • Week 72
|
5.9%
4/68 • Week 72
|
3.1%
2/65 • Week 72
|
3.0%
2/66 • Week 72
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
3/66 • Week 72
|
6.2%
4/65 • Week 72
|
1.5%
1/66 • Week 72
|
3.0%
2/66 • Week 72
|
8.8%
6/68 • Week 72
|
7.7%
5/65 • Week 72
|
4.5%
3/66 • Week 72
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
3/66 • Week 72
|
3.1%
2/65 • Week 72
|
7.6%
5/66 • Week 72
|
9.1%
6/66 • Week 72
|
4.4%
3/68 • Week 72
|
3.1%
2/65 • Week 72
|
7.6%
5/66 • Week 72
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.0%
2/66 • Week 72
|
3.1%
2/65 • Week 72
|
6.1%
4/66 • Week 72
|
7.6%
5/66 • Week 72
|
5.9%
4/68 • Week 72
|
0.00%
0/65 • Week 72
|
3.0%
2/66 • Week 72
|
|
Gastrointestinal disorders
Dyspepsia
|
1.5%
1/66 • Week 72
|
4.6%
3/65 • Week 72
|
4.5%
3/66 • Week 72
|
1.5%
1/66 • Week 72
|
5.9%
4/68 • Week 72
|
4.6%
3/65 • Week 72
|
1.5%
1/66 • Week 72
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.0%
2/66 • Week 72
|
1.5%
1/65 • Week 72
|
3.0%
2/66 • Week 72
|
1.5%
1/66 • Week 72
|
4.4%
3/68 • Week 72
|
6.2%
4/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Gastrointestinal disorders
Toothache
|
1.5%
1/66 • Week 72
|
6.2%
4/65 • Week 72
|
3.0%
2/66 • Week 72
|
3.0%
2/66 • Week 72
|
2.9%
2/68 • Week 72
|
3.1%
2/65 • Week 72
|
3.0%
2/66 • Week 72
|
|
Gastrointestinal disorders
Constipation
|
3.0%
2/66 • Week 72
|
6.2%
4/65 • Week 72
|
3.0%
2/66 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/68 • Week 72
|
3.1%
2/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/66 • Week 72
|
1.5%
1/65 • Week 72
|
6.1%
4/66 • Week 72
|
0.00%
0/66 • Week 72
|
2.9%
2/68 • Week 72
|
0.00%
0/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/66 • Week 72
|
1.5%
1/65 • Week 72
|
6.1%
4/66 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/68 • Week 72
|
0.00%
0/65 • Week 72
|
1.5%
1/66 • Week 72
|
|
Nervous system disorders
Headache
|
27.3%
18/66 • Week 72
|
29.2%
19/65 • Week 72
|
34.8%
23/66 • Week 72
|
43.9%
29/66 • Week 72
|
38.2%
26/68 • Week 72
|
35.4%
23/65 • Week 72
|
36.4%
24/66 • Week 72
|
|
Nervous system disorders
Dizziness
|
1.5%
1/66 • Week 72
|
6.2%
4/65 • Week 72
|
10.6%
7/66 • Week 72
|
9.1%
6/66 • Week 72
|
5.9%
4/68 • Week 72
|
10.8%
7/65 • Week 72
|
9.1%
6/66 • Week 72
|
|
Nervous system disorders
Disturbance in attention
|
4.5%
3/66 • Week 72
|
12.3%
8/65 • Week 72
|
7.6%
5/66 • Week 72
|
1.5%
1/66 • Week 72
|
4.4%
3/68 • Week 72
|
7.7%
5/65 • Week 72
|
4.5%
3/66 • Week 72
|
|
Nervous system disorders
Dysgeusia
|
7.6%
5/66 • Week 72
|
3.1%
2/65 • Week 72
|
9.1%
6/66 • Week 72
|
9.1%
6/66 • Week 72
|
1.5%
1/68 • Week 72
|
3.1%
2/65 • Week 72
|
4.5%
3/66 • Week 72
|
|
Psychiatric disorders
Insomnia
|
16.7%
11/66 • Week 72
|
16.9%
11/65 • Week 72
|
24.2%
16/66 • Week 72
|
16.7%
11/66 • Week 72
|
29.4%
20/68 • Week 72
|
15.4%
10/65 • Week 72
|
13.6%
9/66 • Week 72
|
|
Psychiatric disorders
Depression
|
10.6%
7/66 • Week 72
|
12.3%
8/65 • Week 72
|
12.1%
8/66 • Week 72
|
15.2%
10/66 • Week 72
|
8.8%
6/68 • Week 72
|
9.2%
6/65 • Week 72
|
9.1%
6/66 • Week 72
|
|
Psychiatric disorders
Sleep disorder
|
7.6%
5/66 • Week 72
|
3.1%
2/65 • Week 72
|
7.6%
5/66 • Week 72
|
10.6%
7/66 • Week 72
|
2.9%
2/68 • Week 72
|
7.7%
5/65 • Week 72
|
3.0%
2/66 • Week 72
|
|
Psychiatric disorders
Anxiety
|
7.6%
5/66 • Week 72
|
3.1%
2/65 • Week 72
|
4.5%
3/66 • Week 72
|
3.0%
2/66 • Week 72
|
2.9%
2/68 • Week 72
|
4.6%
3/65 • Week 72
|
4.5%
3/66 • Week 72
|
|
Psychiatric disorders
Depressed mood
|
3.0%
2/66 • Week 72
|
3.1%
2/65 • Week 72
|
4.5%
3/66 • Week 72
|
0.00%
0/66 • Week 72
|
2.9%
2/68 • Week 72
|
7.7%
5/65 • Week 72
|
4.5%
3/66 • Week 72
|
|
Psychiatric disorders
Mood altered
|
3.0%
2/66 • Week 72
|
0.00%
0/65 • Week 72
|
4.5%
3/66 • Week 72
|
6.1%
4/66 • Week 72
|
0.00%
0/68 • Week 72
|
1.5%
1/65 • Week 72
|
3.0%
2/66 • Week 72
|
|
Blood and lymphatic system disorders
Neutropenia
|
24.2%
16/66 • Week 72
|
23.1%
15/65 • Week 72
|
22.7%
15/66 • Week 72
|
25.8%
17/66 • Week 72
|
26.5%
18/68 • Week 72
|
30.8%
20/65 • Week 72
|
16.7%
11/66 • Week 72
|
|
Blood and lymphatic system disorders
Anaemia
|
21.2%
14/66 • Week 72
|
16.9%
11/65 • Week 72
|
18.2%
12/66 • Week 72
|
15.2%
10/66 • Week 72
|
23.5%
16/68 • Week 72
|
20.0%
13/65 • Week 72
|
19.7%
13/66 • Week 72
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.0%
2/66 • Week 72
|
3.1%
2/65 • Week 72
|
1.5%
1/66 • Week 72
|
10.6%
7/66 • Week 72
|
8.8%
6/68 • Week 72
|
7.7%
5/65 • Week 72
|
4.5%
3/66 • Week 72
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/66 • Week 72
|
1.5%
1/65 • Week 72
|
1.5%
1/66 • Week 72
|
6.1%
4/66 • Week 72
|
4.4%
3/68 • Week 72
|
6.2%
4/65 • Week 72
|
3.0%
2/66 • Week 72
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.2%
10/66 • Week 72
|
27.7%
18/65 • Week 72
|
19.7%
13/66 • Week 72
|
16.7%
11/66 • Week 72
|
11.8%
8/68 • Week 72
|
24.6%
16/65 • Week 72
|
12.1%
8/66 • Week 72
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.2%
10/66 • Week 72
|
13.8%
9/65 • Week 72
|
12.1%
8/66 • Week 72
|
6.1%
4/66 • Week 72
|
11.8%
8/68 • Week 72
|
15.4%
10/65 • Week 72
|
6.1%
4/66 • Week 72
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.1%
4/66 • Week 72
|
6.2%
4/65 • Week 72
|
6.1%
4/66 • Week 72
|
3.0%
2/66 • Week 72
|
4.4%
3/68 • Week 72
|
4.6%
3/65 • Week 72
|
4.5%
3/66 • Week 72
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
1/66 • Week 72
|
4.6%
3/65 • Week 72
|
4.5%
3/66 • Week 72
|
6.1%
4/66 • Week 72
|
2.9%
2/68 • Week 72
|
1.5%
1/65 • Week 72
|
6.1%
4/66 • Week 72
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/66 • Week 72
|
0.00%
0/65 • Week 72
|
6.1%
4/66 • Week 72
|
1.5%
1/66 • Week 72
|
1.5%
1/68 • Week 72
|
3.1%
2/65 • Week 72
|
1.5%
1/66 • Week 72
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.0%
2/66 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
0.00%
0/66 • Week 72
|
4.4%
3/68 • Week 72
|
1.5%
1/65 • Week 72
|
7.6%
5/66 • Week 72
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
24.2%
16/66 • Week 72
|
6.2%
4/65 • Week 72
|
9.1%
6/66 • Week 72
|
16.7%
11/66 • Week 72
|
16.2%
11/68 • Week 72
|
24.6%
16/65 • Week 72
|
18.2%
12/66 • Week 72
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
7/66 • Week 72
|
7.7%
5/65 • Week 72
|
13.6%
9/66 • Week 72
|
22.7%
15/66 • Week 72
|
10.3%
7/68 • Week 72
|
10.8%
7/65 • Week 72
|
13.6%
9/66 • Week 72
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
2/66 • Week 72
|
3.1%
2/65 • Week 72
|
3.0%
2/66 • Week 72
|
4.5%
3/66 • Week 72
|
13.2%
9/68 • Week 72
|
3.1%
2/65 • Week 72
|
12.1%
8/66 • Week 72
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.1%
4/66 • Week 72
|
4.6%
3/65 • Week 72
|
1.5%
1/66 • Week 72
|
4.5%
3/66 • Week 72
|
5.9%
4/68 • Week 72
|
1.5%
1/65 • Week 72
|
6.1%
4/66 • Week 72
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
1/66 • Week 72
|
10.8%
7/65 • Week 72
|
1.5%
1/66 • Week 72
|
3.0%
2/66 • Week 72
|
5.9%
4/68 • Week 72
|
4.6%
3/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Infections and infestations
Sinusitis
|
10.6%
7/66 • Week 72
|
0.00%
0/65 • Week 72
|
4.5%
3/66 • Week 72
|
1.5%
1/66 • Week 72
|
4.4%
3/68 • Week 72
|
0.00%
0/65 • Week 72
|
4.5%
3/66 • Week 72
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
4/66 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
3.0%
2/66 • Week 72
|
0.00%
0/68 • Week 72
|
4.6%
3/65 • Week 72
|
3.0%
2/66 • Week 72
|
|
Investigations
Weight decreased
|
6.1%
4/66 • Week 72
|
4.6%
3/65 • Week 72
|
4.5%
3/66 • Week 72
|
7.6%
5/66 • Week 72
|
4.4%
3/68 • Week 72
|
10.8%
7/65 • Week 72
|
4.5%
3/66 • Week 72
|
|
Investigations
Neutrophil count decreased
|
3.0%
2/66 • Week 72
|
7.7%
5/65 • Week 72
|
0.00%
0/66 • Week 72
|
3.0%
2/66 • Week 72
|
1.5%
1/68 • Week 72
|
3.1%
2/65 • Week 72
|
3.0%
2/66 • Week 72
|
|
Investigations
Alanine aminotransferase increased
|
3.0%
2/66 • Week 72
|
3.1%
2/65 • Week 72
|
1.5%
1/66 • Week 72
|
1.5%
1/66 • Week 72
|
0.00%
0/68 • Week 72
|
6.2%
4/65 • Week 72
|
1.5%
1/66 • Week 72
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/66 • Week 72
|
1.5%
1/65 • Week 72
|
0.00%
0/66 • Week 72
|
4.5%
3/66 • Week 72
|
5.9%
4/68 • Week 72
|
0.00%
0/65 • Week 72
|
1.5%
1/66 • Week 72
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
11/66 • Week 72
|
16.9%
11/65 • Week 72
|
16.7%
11/66 • Week 72
|
19.7%
13/66 • Week 72
|
19.1%
13/68 • Week 72
|
15.4%
10/65 • Week 72
|
13.6%
9/66 • Week 72
|
|
Eye disorders
Dry eye
|
1.5%
1/66 • Week 72
|
6.2%
4/65 • Week 72
|
6.1%
4/66 • Week 72
|
0.00%
0/66 • Week 72
|
4.4%
3/68 • Week 72
|
3.1%
2/65 • Week 72
|
1.5%
1/66 • Week 72
|
|
Injury, poisoning and procedural complications
Sunburn
|
1.5%
1/66 • Week 72
|
0.00%
0/65 • Week 72
|
3.0%
2/66 • Week 72
|
3.0%
2/66 • Week 72
|
0.00%
0/68 • Week 72
|
7.7%
5/65 • Week 72
|
0.00%
0/66 • Week 72
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
4.5%
3/66 • Week 72
|
1.5%
1/65 • Week 72
|
3.0%
2/66 • Week 72
|
3.0%
2/66 • Week 72
|
10.3%
7/68 • Week 72
|
4.6%
3/65 • Week 72
|
1.5%
1/66 • Week 72
|
|
Ear and labyrinth disorders
Vertigo
|
3.0%
2/66 • Week 72
|
6.2%
4/65 • Week 72
|
6.1%
4/66 • Week 72
|
0.00%
0/66 • Week 72
|
4.4%
3/68 • Week 72
|
1.5%
1/65 • Week 72
|
6.1%
4/66 • Week 72
|
|
Endocrine disorders
Hypothyroidism
|
1.5%
1/66 • Week 72
|
1.5%
1/65 • Week 72
|
3.0%
2/66 • Week 72
|
0.00%
0/66 • Week 72
|
5.9%
4/68 • Week 72
|
1.5%
1/65 • Week 72
|
1.5%
1/66 • Week 72
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60