Trial Outcomes & Findings for The Individualized Management With Pegylated-interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Offering Viral Eradication: A Study of Pegylated-interferon Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C (CHC) Non-genotype 2/3 (IMPROVE) (NCT NCT00483938)
NCT ID: NCT00483938
Last Updated: 2017-01-23
Results Overview
SVR was defined as success if the participant had HCV RNA levels \<15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups A and B was reported in this analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
236 participants
Primary outcome timeframe
At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B)
Results posted on
2017-01-23
Participant Flow
Participant milestones
| Measure |
Pegylated-interferon Alfa-2a + Ribavirin (Group A)
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (\>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (\>=) 15 IU/mL at Week 8, and either HCV RNA less than (\<) 15 IU/mL or \>=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group B)
Participants with HCV RNA levels \>15 IU/mL at Week 4, HCV RNA \>=15 IU/mL at Week 8, and either HCV RNA \<15 IU/mL or \>=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group C)
Participants with HCV-RNA levels \>15 IU/mL at Week 4, and HCV-RNA \<15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group D)
Participants with HCV-RNA levels \>15 IU/mL at Week 4, and HCV-RNA \<15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group E)
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group F)
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group NR)
Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
43
|
30
|
31
|
25
|
26
|
40
|
|
Overall Study
COMPLETED
|
36
|
24
|
30
|
25
|
23
|
18
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
19
|
0
|
6
|
2
|
8
|
40
|
Reasons for withdrawal
| Measure |
Pegylated-interferon Alfa-2a + Ribavirin (Group A)
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (\>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (\>=) 15 IU/mL at Week 8, and either HCV RNA less than (\<) 15 IU/mL or \>=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group B)
Participants with HCV RNA levels \>15 IU/mL at Week 4, HCV RNA \>=15 IU/mL at Week 8, and either HCV RNA \<15 IU/mL or \>=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group C)
Participants with HCV-RNA levels \>15 IU/mL at Week 4, and HCV-RNA \<15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group D)
Participants with HCV-RNA levels \>15 IU/mL at Week 4, and HCV-RNA \<15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group E)
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group F)
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group NR)
Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
6
|
0
|
0
|
1
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
2
|
1
|
1
|
3
|
|
Overall Study
Death
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
3
|
9
|
0
|
4
|
0
|
4
|
32
|
Baseline Characteristics
The Individualized Management With Pegylated-interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Offering Viral Eradication: A Study of Pegylated-interferon Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C (CHC) Non-genotype 2/3 (IMPROVE)
Baseline characteristics by cohort
| Measure |
Pegylated-interferon Alfa-2a + Ribavirin (Group A)
n=41 Participants
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (\>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (\>=) 15 IU/mL at Week 8, and either HCV RNA less than (\<) 15 IU/mL or \>=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group B)
n=43 Participants
Participants with HCV RNA levels \>15 IU/mL at Week 4, HCV RNA \>=15 IU/mL at Week 8, and either HCV RNA \<15 IU/mL or \>=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group C)
n=30 Participants
Participants with HCV-RNA levels \>15 IU/mL at Week 4, and HCV-RNA \<15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group D)
n=31 Participants
Participants with HCV-RNA levels \>15 IU/mL at Week 4, and HCV-RNA \<15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group E)
n=25 Participants
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group F)
n=26 Participants
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group NR)
n=40 Participants
Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 8.55 • n=5 Participants
|
51.0 years
STANDARD_DEVIATION 7.39 • n=7 Participants
|
48.7 years
STANDARD_DEVIATION 11.54 • n=5 Participants
|
47.8 years
STANDARD_DEVIATION 9.16 • n=4 Participants
|
47.0 years
STANDARD_DEVIATION 10.38 • n=21 Participants
|
47.0 years
STANDARD_DEVIATION 9.76 • n=8 Participants
|
51.7 years
STANDARD_DEVIATION 7.52 • n=8 Participants
|
49.5 years
STANDARD_DEVIATION 9.13 • n=24 Participants
|
|
Gender
Female
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
85 Participants
n=24 Participants
|
|
Gender
Male
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
151 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B)Population: Intent-to-treat (ITT) population included randomized participants who received at least one dose of study medication and who had a baseline HCV-RNA which was at least 15 IU/mL. Here, "Number of Participants Analyzed" = the participants who were evaluable for this outcome measure.
SVR was defined as success if the participant had HCV RNA levels \<15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups A and B was reported in this analysis.
Outcome measures
| Measure |
Pegylated-interferon Alfa-2a + Ribavirin (Group A)
n=41 Participants
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (\>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (\>=) 15 IU/mL at Week 8, and either HCV RNA less than (\<) 15 IU/mL or \>=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group B)
n=43 Participants
Participants with HCV RNA levels \>15 IU/mL at Week 4, HCV RNA \>=15 IU/mL at Week 8, and either HCV RNA \<15 IU/mL or \>=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group E)
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group F)
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group E)
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group F)
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B)
|
48.8 percentage of participants
|
39.5 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 24-week untreated follow-up visit (up to 60, 72, 48, and 72 weeks for Groups C, D, E, and F, respectively)Population: ITT. Here, "Number of Participants Analyzed" = the participants who were evaluable for this outcome measure.
SVR was defined as success if the participant had HCV RNA levels \<15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups C, D, E, and F was reported in this analysis.
Outcome measures
| Measure |
Pegylated-interferon Alfa-2a + Ribavirin (Group A)
n=30 Participants
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (\>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (\>=) 15 IU/mL at Week 8, and either HCV RNA less than (\<) 15 IU/mL or \>=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group B)
n=31 Participants
Participants with HCV RNA levels \>15 IU/mL at Week 4, HCV RNA \>=15 IU/mL at Week 8, and either HCV RNA \<15 IU/mL or \>=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group E)
n=25 Participants
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group F)
n=25 Participants
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group E)
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group F)
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With SVR (Groups C, D, E, and F)
|
73.3 percentage of participants
|
74.2 percentage of participants
|
84.0 percentage of participants
|
84.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12 (Groups C, D, E, and F), and end of treatment (Weeks 48, 72, 36, 48, 24, and 48 for Groups A, B, C, D, E, and F, respectively)Population: ITT population
End of treatment response (ETR) was defined as "Success" if the HCV-RNA levels were \<15 IU/mL at the end of treatment. Early virological response (EVR) was defined as \>=2 log10 decrease in serum HCV RNA or undetectable serum HCV RNA (\<15 IU/mL) at Week 12. Complete EVR was defined as "Success", if the HCV-RNA levels were \<15 IU/mL at Week 12. Partial EVR was defined as "Success", if there was a \>=2 log10 drop in HCV-RNA at Week 12 compared to baseline but with a level that was still \>=15 IU/mL at that time point.
Outcome measures
| Measure |
Pegylated-interferon Alfa-2a + Ribavirin (Group A)
n=41 Participants
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (\>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (\>=) 15 IU/mL at Week 8, and either HCV RNA less than (\<) 15 IU/mL or \>=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group B)
n=43 Participants
Participants with HCV RNA levels \>15 IU/mL at Week 4, HCV RNA \>=15 IU/mL at Week 8, and either HCV RNA \<15 IU/mL or \>=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group E)
n=30 Participants
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group F)
n=31 Participants
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group E)
n=25 Participants
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group F)
n=25 Participants
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F)
ETR
|
80.5 percentage of participants
|
76.7 percentage of participants
|
96.7 percentage of participants
|
90.3 percentage of participants
|
92.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F)
Complete EVR
|
0 percentage of participants
|
0 percentage of participants
|
93.3 percentage of participants
|
96.8 percentage of participants
|
88.0 percentage of participants
|
92.0 percentage of participants
|
|
Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F)
Partial EVR
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Pegylated-interferon Alfa-2a + Ribavirin (Group A)
Serious events: 4 serious events
Other events: 39 other events
Deaths: 0 deaths
Pegylated-interferon Alfa-2a + Ribavirin (Group B)
Serious events: 6 serious events
Other events: 43 other events
Deaths: 0 deaths
Pegylated-interferon Alfa-2a + Ribavirin (Group C)
Serious events: 5 serious events
Other events: 30 other events
Deaths: 0 deaths
Pegylated-interferon Alfa-2a + Ribavirin (Group D)
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Pegylated-interferon Alfa-2a + Ribavirin (Group E)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Pegylated-interferon Alfa-2a + Ribavirin (Group F)
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Pegylated-interferon Alfa-2a + Ribavirin (Group NR)
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pegylated-interferon Alfa-2a + Ribavirin (Group A)
n=41 participants at risk
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (\>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (\>=) 15 IU/mL at Week 8, and either HCV RNA less than (\<) 15 IU/mL or \>=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group B)
n=43 participants at risk
Participants with HCV RNA levels \>15 IU/mL at Week 4, HCV RNA \>=15 IU/mL at Week 8, and either HCV RNA \<15 IU/mL or \>=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group C)
n=30 participants at risk
Participants with HCV-RNA levels \>15 IU/mL at Week 4, and HCV-RNA \<15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group D)
n=31 participants at risk
Participants with HCV-RNA levels \>15 IU/mL at Week 4, and HCV-RNA \<15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group E)
n=25 participants at risk
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group F)
n=26 participants at risk
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group NR)
n=40 participants at risk
Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
3.8%
1/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
3.3%
1/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Gastrointestinal disorders
Caecitis
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
3.3%
1/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
General disorders
Chest pain
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
3.3%
1/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
2.4%
1/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Infections and infestations
Appendicitis
|
2.4%
1/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Infections and infestations
Cellulitis
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
3.8%
1/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Infections and infestations
Kidney infection
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
2.4%
1/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Nervous system disorders
Hepatic encephalopathy
|
2.4%
1/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Nervous system disorders
Syncope
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
3.8%
1/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Psychiatric disorders
Emotional/mental (depression, anxiety, irritability, forgetfulness, confusion, anger)
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
3.8%
1/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Social circumstances
Pregnancy of partner
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
6.7%
2/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
Other adverse events
| Measure |
Pegylated-interferon Alfa-2a + Ribavirin (Group A)
n=41 participants at risk
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (\>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (\>=) 15 IU/mL at Week 8, and either HCV RNA less than (\<) 15 IU/mL or \>=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group B)
n=43 participants at risk
Participants with HCV RNA levels \>15 IU/mL at Week 4, HCV RNA \>=15 IU/mL at Week 8, and either HCV RNA \<15 IU/mL or \>=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group C)
n=30 participants at risk
Participants with HCV-RNA levels \>15 IU/mL at Week 4, and HCV-RNA \<15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group D)
n=31 participants at risk
Participants with HCV-RNA levels \>15 IU/mL at Week 4, and HCV-RNA \<15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group E)
n=25 participants at risk
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group F)
n=26 participants at risk
Participants with HCV-RNA levels \<15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
Pegylated-interferon Alfa-2a + Ribavirin (Group NR)
n=40 participants at risk
Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
29.3%
12/41 • Baseline up to 96 weeks
Safety population
|
37.2%
16/43 • Baseline up to 96 weeks
Safety population
|
16.7%
5/30 • Baseline up to 96 weeks
Safety population
|
22.6%
7/31 • Baseline up to 96 weeks
Safety population
|
16.0%
4/25 • Baseline up to 96 weeks
Safety population
|
15.4%
4/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.0%
9/41 • Baseline up to 96 weeks
Safety population
|
20.9%
9/43 • Baseline up to 96 weeks
Safety population
|
26.7%
8/30 • Baseline up to 96 weeks
Safety population
|
9.7%
3/31 • Baseline up to 96 weeks
Safety population
|
24.0%
6/25 • Baseline up to 96 weeks
Safety population
|
34.6%
9/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.9%
2/41 • Baseline up to 96 weeks
Safety population
|
7.0%
3/43 • Baseline up to 96 weeks
Safety population
|
6.7%
2/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
4.0%
1/25 • Baseline up to 96 weeks
Safety population
|
3.8%
1/26 • Baseline up to 96 weeks
Safety population
|
5.0%
2/40 • Baseline up to 96 weeks
Safety population
|
|
Endocrine disorders
Hyperthyroidism
|
4.9%
2/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
3.3%
1/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
8.0%
2/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Endocrine disorders
Hypothyroidism
|
2.4%
1/41 • Baseline up to 96 weeks
Safety population
|
4.7%
2/43 • Baseline up to 96 weeks
Safety population
|
6.7%
2/30 • Baseline up to 96 weeks
Safety population
|
6.5%
2/31 • Baseline up to 96 weeks
Safety population
|
4.0%
1/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Eye disorders
Dry eye
|
7.3%
3/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
6.7%
2/30 • Baseline up to 96 weeks
Safety population
|
6.5%
2/31 • Baseline up to 96 weeks
Safety population
|
4.0%
1/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
1/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
3.3%
1/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
7.7%
2/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Gastrointestinal disorders
Dry mouth
|
4.9%
2/41 • Baseline up to 96 weeks
Safety population
|
4.7%
2/43 • Baseline up to 96 weeks
Safety population
|
6.7%
2/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
2/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
11.5%
3/26 • Baseline up to 96 weeks
Safety population
|
5.0%
2/40 • Baseline up to 96 weeks
Safety population
|
|
Gastrointestinal disorders
Gastrointestinal symptoms (diarrhea, bloating, gas)
|
34.1%
14/41 • Baseline up to 96 weeks
Safety population
|
20.9%
9/43 • Baseline up to 96 weeks
Safety population
|
40.0%
12/30 • Baseline up to 96 weeks
Safety population
|
35.5%
11/31 • Baseline up to 96 weeks
Safety population
|
4.0%
1/25 • Baseline up to 96 weeks
Safety population
|
23.1%
6/26 • Baseline up to 96 weeks
Safety population
|
10.0%
4/40 • Baseline up to 96 weeks
Safety population
|
|
Gastrointestinal disorders
Nausea
|
26.8%
11/41 • Baseline up to 96 weeks
Safety population
|
23.3%
10/43 • Baseline up to 96 weeks
Safety population
|
16.7%
5/30 • Baseline up to 96 weeks
Safety population
|
25.8%
8/31 • Baseline up to 96 weeks
Safety population
|
28.0%
7/25 • Baseline up to 96 weeks
Safety population
|
15.4%
4/26 • Baseline up to 96 weeks
Safety population
|
12.5%
5/40 • Baseline up to 96 weeks
Safety population
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
7.7%
2/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Gastrointestinal disorders
Vomiting
|
9.8%
4/41 • Baseline up to 96 weeks
Safety population
|
4.7%
2/43 • Baseline up to 96 weeks
Safety population
|
10.0%
3/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
8.0%
2/25 • Baseline up to 96 weeks
Safety population
|
7.7%
2/26 • Baseline up to 96 weeks
Safety population
|
5.0%
2/40 • Baseline up to 96 weeks
Safety population
|
|
General disorders
Asthenia
|
7.3%
3/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
3.3%
1/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
4.0%
1/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
General disorders
Fatigue
|
43.9%
18/41 • Baseline up to 96 weeks
Safety population
|
51.2%
22/43 • Baseline up to 96 weeks
Safety population
|
50.0%
15/30 • Baseline up to 96 weeks
Safety population
|
25.8%
8/31 • Baseline up to 96 weeks
Safety population
|
40.0%
10/25 • Baseline up to 96 weeks
Safety population
|
46.2%
12/26 • Baseline up to 96 weeks
Safety population
|
15.0%
6/40 • Baseline up to 96 weeks
Safety population
|
|
General disorders
Feeling abnormal
|
7.3%
3/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
3.8%
1/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
General disorders
Flu-like symptoms (fever, chills, headache, aches/pains)
|
90.2%
37/41 • Baseline up to 96 weeks
Safety population
|
74.4%
32/43 • Baseline up to 96 weeks
Safety population
|
76.7%
23/30 • Baseline up to 96 weeks
Safety population
|
77.4%
24/31 • Baseline up to 96 weeks
Safety population
|
64.0%
16/25 • Baseline up to 96 weeks
Safety population
|
80.8%
21/26 • Baseline up to 96 weeks
Safety population
|
70.0%
28/40 • Baseline up to 96 weeks
Safety population
|
|
Infections and infestations
Ear infection
|
2.4%
1/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
7.7%
2/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
2/41 • Baseline up to 96 weeks
Safety population
|
4.7%
2/43 • Baseline up to 96 weeks
Safety population
|
6.7%
2/30 • Baseline up to 96 weeks
Safety population
|
9.7%
3/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
11.5%
3/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Infections and infestations
Tooth infection
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
7.7%
2/26 • Baseline up to 96 weeks
Safety population
|
5.0%
2/40 • Baseline up to 96 weeks
Safety population
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
4.7%
2/43 • Baseline up to 96 weeks
Safety population
|
6.7%
2/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
3.8%
1/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
9.3%
4/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
6.5%
2/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
3.8%
1/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
6.5%
2/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Investigations
Haemoglobin decreased
|
7.3%
3/41 • Baseline up to 96 weeks
Safety population
|
4.7%
2/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
4.0%
1/25 • Baseline up to 96 weeks
Safety population
|
11.5%
3/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Investigations
Weight decreased
|
7.3%
3/41 • Baseline up to 96 weeks
Safety population
|
4.7%
2/43 • Baseline up to 96 weeks
Safety population
|
6.7%
2/30 • Baseline up to 96 weeks
Safety population
|
9.7%
3/31 • Baseline up to 96 weeks
Safety population
|
8.0%
2/25 • Baseline up to 96 weeks
Safety population
|
7.7%
2/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.5%
8/41 • Baseline up to 96 weeks
Safety population
|
11.6%
5/43 • Baseline up to 96 weeks
Safety population
|
13.3%
4/30 • Baseline up to 96 weeks
Safety population
|
9.7%
3/31 • Baseline up to 96 weeks
Safety population
|
16.0%
4/25 • Baseline up to 96 weeks
Safety population
|
23.1%
6/26 • Baseline up to 96 weeks
Safety population
|
12.5%
5/40 • Baseline up to 96 weeks
Safety population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
2/41 • Baseline up to 96 weeks
Safety population
|
9.3%
4/43 • Baseline up to 96 weeks
Safety population
|
6.7%
2/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
7.7%
2/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
2/41 • Baseline up to 96 weeks
Safety population
|
4.7%
2/43 • Baseline up to 96 weeks
Safety population
|
10.0%
3/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.2%
5/41 • Baseline up to 96 weeks
Safety population
|
4.7%
2/43 • Baseline up to 96 weeks
Safety population
|
6.7%
2/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
4.0%
1/25 • Baseline up to 96 weeks
Safety population
|
3.8%
1/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
7.0%
3/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
3.8%
1/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Nervous system disorders
Dizziness
|
14.6%
6/41 • Baseline up to 96 weeks
Safety population
|
16.3%
7/43 • Baseline up to 96 weeks
Safety population
|
10.0%
3/30 • Baseline up to 96 weeks
Safety population
|
16.1%
5/31 • Baseline up to 96 weeks
Safety population
|
4.0%
1/25 • Baseline up to 96 weeks
Safety population
|
11.5%
3/26 • Baseline up to 96 weeks
Safety population
|
5.0%
2/40 • Baseline up to 96 weeks
Safety population
|
|
Nervous system disorders
Dysgeusia
|
2.4%
1/41 • Baseline up to 96 weeks
Safety population
|
4.7%
2/43 • Baseline up to 96 weeks
Safety population
|
6.7%
2/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
8.0%
2/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Nervous system disorders
Headache
|
12.2%
5/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
23.3%
7/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
8.0%
2/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
5.0%
2/40 • Baseline up to 96 weeks
Safety population
|
|
Nervous system disorders
Lethargy
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
4.7%
2/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
9.7%
3/31 • Baseline up to 96 weeks
Safety population
|
12.0%
3/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
7.5%
3/40 • Baseline up to 96 weeks
Safety population
|
|
Nervous system disorders
Syncope
|
2.4%
1/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
7.7%
2/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Psychiatric disorders
Emotional/mental (depression, anxiety, irritability, forgetfulness, confusion, anger)
|
51.2%
21/41 • Baseline up to 96 weeks
Safety population
|
58.1%
25/43 • Baseline up to 96 weeks
Safety population
|
50.0%
15/30 • Baseline up to 96 weeks
Safety population
|
54.8%
17/31 • Baseline up to 96 weeks
Safety population
|
44.0%
11/25 • Baseline up to 96 weeks
Safety population
|
57.7%
15/26 • Baseline up to 96 weeks
Safety population
|
32.5%
13/40 • Baseline up to 96 weeks
Safety population
|
|
Psychiatric disorders
Insomnia
|
39.0%
16/41 • Baseline up to 96 weeks
Safety population
|
41.9%
18/43 • Baseline up to 96 weeks
Safety population
|
33.3%
10/30 • Baseline up to 96 weeks
Safety population
|
19.4%
6/31 • Baseline up to 96 weeks
Safety population
|
16.0%
4/25 • Baseline up to 96 weeks
Safety population
|
42.3%
11/26 • Baseline up to 96 weeks
Safety population
|
32.5%
13/40 • Baseline up to 96 weeks
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.6%
6/41 • Baseline up to 96 weeks
Safety population
|
9.3%
4/43 • Baseline up to 96 weeks
Safety population
|
23.3%
7/30 • Baseline up to 96 weeks
Safety population
|
9.7%
3/31 • Baseline up to 96 weeks
Safety population
|
12.0%
3/25 • Baseline up to 96 weeks
Safety population
|
7.7%
2/26 • Baseline up to 96 weeks
Safety population
|
10.0%
4/40 • Baseline up to 96 weeks
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.0%
9/41 • Baseline up to 96 weeks
Safety population
|
14.0%
6/43 • Baseline up to 96 weeks
Safety population
|
20.0%
6/30 • Baseline up to 96 weeks
Safety population
|
12.9%
4/31 • Baseline up to 96 weeks
Safety population
|
12.0%
3/25 • Baseline up to 96 weeks
Safety population
|
11.5%
3/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.4%
1/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
10.0%
3/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
4.0%
1/25 • Baseline up to 96 weeks
Safety population
|
3.8%
1/26 • Baseline up to 96 weeks
Safety population
|
5.0%
2/40 • Baseline up to 96 weeks
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.3%
3/41 • Baseline up to 96 weeks
Safety population
|
4.7%
2/43 • Baseline up to 96 weeks
Safety population
|
20.0%
6/30 • Baseline up to 96 weeks
Safety population
|
0.00%
0/31 • Baseline up to 96 weeks
Safety population
|
8.0%
2/25 • Baseline up to 96 weeks
Safety population
|
7.7%
2/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
6.7%
2/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
4.0%
1/25 • Baseline up to 96 weeks
Safety population
|
0.00%
0/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.8%
4/41 • Baseline up to 96 weeks
Safety population
|
20.9%
9/43 • Baseline up to 96 weeks
Safety population
|
26.7%
8/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
16.0%
4/25 • Baseline up to 96 weeks
Safety population
|
15.4%
4/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.4%
1/41 • Baseline up to 96 weeks
Safety population
|
2.3%
1/43 • Baseline up to 96 weeks
Safety population
|
13.3%
4/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
8.0%
2/25 • Baseline up to 96 weeks
Safety population
|
3.8%
1/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
3.3%
1/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
8.0%
2/25 • Baseline up to 96 weeks
Safety population
|
7.7%
2/26 • Baseline up to 96 weeks
Safety population
|
2.5%
1/40 • Baseline up to 96 weeks
Safety population
|
|
Skin and subcutaneous tissue disorders
Skin (injection site reactions, rashes, pruritus)
|
58.5%
24/41 • Baseline up to 96 weeks
Safety population
|
55.8%
24/43 • Baseline up to 96 weeks
Safety population
|
66.7%
20/30 • Baseline up to 96 weeks
Safety population
|
51.6%
16/31 • Baseline up to 96 weeks
Safety population
|
48.0%
12/25 • Baseline up to 96 weeks
Safety population
|
69.2%
18/26 • Baseline up to 96 weeks
Safety population
|
40.0%
16/40 • Baseline up to 96 weeks
Safety population
|
|
Vascular disorders
Hot flush
|
7.3%
3/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
0.00%
0/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
3.8%
1/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
|
Vascular disorders
Hypertension
|
2.4%
1/41 • Baseline up to 96 weeks
Safety population
|
0.00%
0/43 • Baseline up to 96 weeks
Safety population
|
6.7%
2/30 • Baseline up to 96 weeks
Safety population
|
3.2%
1/31 • Baseline up to 96 weeks
Safety population
|
0.00%
0/25 • Baseline up to 96 weeks
Safety population
|
3.8%
1/26 • Baseline up to 96 weeks
Safety population
|
0.00%
0/40 • Baseline up to 96 weeks
Safety population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER