Trial Outcomes & Findings for A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB). (NCT NCT00435825)
NCT ID: NCT00435825
Last Updated: 2013-06-25
Results Overview
Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe) determined at 24 weeks after the end of treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
551 participants
Primary outcome timeframe
24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Results posted on
2013-06-25
Participant Flow
Participant milestones
| Measure |
Peginterferon Alfa-2a 90 μg_24 Weeks
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 180 μg_24 Weeks
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 90 μg_48 Weeks
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Peginterferon Alfa-2a 180 μg_48 Weeks
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
141
|
136
|
138
|
136
|
|
Overall Study
Received Study Drug
|
140
|
136
|
136
|
136
|
|
Overall Study
Entered Follow-up
|
140
|
132
|
135
|
133
|
|
Overall Study
Completed 24 Weeks Treatment
|
128
|
126
|
134
|
131
|
|
Overall Study
Completed 48 Weeks Treatment
|
0
|
0
|
124
|
117
|
|
Overall Study
COMPLETED
|
123
|
124
|
127
|
120
|
|
Overall Study
NOT COMPLETED
|
18
|
12
|
11
|
16
|
Reasons for withdrawal
| Measure |
Peginterferon Alfa-2a 90 μg_24 Weeks
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 180 μg_24 Weeks
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 90 μg_48 Weeks
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Peginterferon Alfa-2a 180 μg_48 Weeks
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
|---|---|---|---|---|
|
Overall Study
Abnormality of Laboratory Test
|
0
|
1
|
0
|
0
|
|
Overall Study
Insufficient Therapeutic Response
|
3
|
1
|
0
|
3
|
|
Overall Study
Other Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Refused treatment
|
2
|
0
|
0
|
5
|
|
Overall Study
Failure to return
|
5
|
0
|
4
|
0
|
|
Overall Study
Did not receive study drug
|
1
|
0
|
2
|
0
|
|
Overall Study
Did not enter follow-up
|
0
|
4
|
1
|
3
|
|
Overall Study
Did not complete full follow-up period
|
6
|
6
|
4
|
5
|
Baseline Characteristics
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).
Baseline characteristics by cohort
| Measure |
Peginterferon Alfa-2a 90 μg_24 Weeks
n=140 Participants
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 180 μg_24 Weeks
n=136 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 90 μg_48 Weeks
n=136 Participants
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Peginterferon Alfa-2a 180 μg_48 Weeks
n=136 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Total
n=548 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
|
31.8 Years
FULL_RANGE 9.77 • n=5 Participants
|
33.0 Years
FULL_RANGE 10.52 • n=7 Participants
|
33.8 Years
FULL_RANGE 10.48 • n=5 Participants
|
33.3 Years
FULL_RANGE 10.89 • n=4 Participants
|
32.98 Years
n=21 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
171 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
377 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe) determined at 24 weeks after the end of treatment.
Outcome measures
| Measure |
Peginterferon Alfa-2a 90 μg_24 Weeks
n=142 Participants
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 180 μg_24 Weeks
n=140 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 90 μg_48 Weeks
n=132 Participants
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Peginterferon Alfa-2a 180 μg_48 Weeks
n=130 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment
|
14.08 Percentage of participants
Interval 8.82 to 20.91
|
22.86 Percentage of participants
Interval 16.19 to 30.71
|
25.76 Percentage of participants
Interval 18.54 to 34.09
|
36.15 Percentage of participants
Interval 27.91 to 45.04
|
SECONDARY outcome
Timeframe: Week 72Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBs) determined at Week 72.
Outcome measures
| Measure |
Peginterferon Alfa-2a 90 μg_24 Weeks
n=142 Participants
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 180 μg_24 Weeks
n=140 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 90 μg_48 Weeks
n=132 Participants
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Peginterferon Alfa-2a 180 μg_48 Weeks
n=130 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72
|
18.31 Percentage of participants
Interval 12.32 to 25.67
|
27.14 Percentage of participants
Interval 19.98 to 35.3
|
25.76 Percentage of participants
Interval 18.54 to 34.09
|
36.15 Percentage of participants
Interval 27.91 to 45.04
|
SECONDARY outcome
Timeframe: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the Per protocol population switched treatment groups for the analysis.
Blood was collected HBeAg 24 Weeks following the end of treatment. Loss of HBeAg is defined as the absence of HBeAg.
Outcome measures
| Measure |
Peginterferon Alfa-2a 90 μg_24 Weeks
n=142 Participants
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 180 μg_24 Weeks
n=140 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 90 μg_48 Weeks
n=132 Participants
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Peginterferon Alfa-2a 180 μg_48 Weeks
n=130 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment
|
14.79 Percentage of participants
Interval 9.39 to 21.71
|
22.86 Percentage of participants
Interval 16.19 to 30.71
|
26.52 Percentage of participants
Interval 19.21 to 34.9
|
36.15 Percentage of participants
Interval 27.91 to 45.04
|
SECONDARY outcome
Timeframe: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs) determined at 24 weeks after the end of treatment.
Outcome measures
| Measure |
Peginterferon Alfa-2a 90 μg_24 Weeks
n=142 Participants
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 180 μg_24 Weeks
n=140 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 90 μg_48 Weeks
n=132 Participants
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Peginterferon Alfa-2a 180 μg_48 Weeks
n=130 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment
|
0.0 Percentage of participants
Interval 0.0 to 2.56
|
0.0 Percentage of participants
Interval 0.0 to 2.6
|
1.52 Percentage of participants
Interval 0.18 to 5.37
|
2.31 Percentage of participants
Interval 0.48 to 6.6
|
SECONDARY outcome
Timeframe: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
Blood was collected for HBsAg 24 weeks following the end of treatment. Loss of HBsAg is defined as the absence of HBsAg.
Outcome measures
| Measure |
Peginterferon Alfa-2a 90 μg_24 Weeks
n=142 Participants
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 180 μg_24 Weeks
n=140 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 90 μg_48 Weeks
n=132 Participants
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Peginterferon Alfa-2a 180 μg_48 Weeks
n=130 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment
|
0.70 Percentage of participants
Interval 0.02 to 3.86
|
0.0 Percentage of participants
Interval 0.0 to 2.6
|
2.27 Percentage of participants
Interval 0.47 to 6.5
|
2.31 Percentage of participants
Interval 0.48 to 6.6
|
SECONDARY outcome
Timeframe: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay.
Outcome measures
| Measure |
Peginterferon Alfa-2a 90 μg_24 Weeks
n=142 Participants
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 180 μg_24 Weeks
n=140 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 90 μg_48 Weeks
n=132 Participants
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Peginterferon Alfa-2a 180 μg_48 Weeks
n=130 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Normal Alanine Aminotransferase (ALT)
|
30.28 Percentage of participants
Interval 22.86 to 38.55
|
30.71 Percentage of participants
Interval 23.2 to 39.06
|
43.18 Percentage of participants
Interval 34.59 to 52.08
|
52.31 Percentage of participants
Interval 43.37 to 61.14
|
SECONDARY outcome
Timeframe: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
Blood was collected for HBV-DNA 24 weeks following the end of treatment and was analyzed at the central laboratory using the Roche approved polymerase chain reaction (PCR) methodology. Percentage of participants with a HBV-DNA suppression of \< 20,000 IU/mL (Less than 100,000 copies/mL) is reported.
Outcome measures
| Measure |
Peginterferon Alfa-2a 90 μg_24 Weeks
n=142 Participants
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 180 μg_24 Weeks
n=140 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 90 μg_48 Weeks
n=132 Participants
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Peginterferon Alfa-2a 180 μg_48 Weeks
n=130 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment
|
21.83 Percentage of participants
Interval 15.34 to 29.53
|
21.43 Percentage of participants
Interval 14.95 to 29.16
|
32.58 Percentage of participants
Interval 24.68 to 41.27
|
42.31 Percentage of participants
Interval 33.7 to 51.28
|
SECONDARY outcome
Timeframe: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment of Week 72 for 48 Week Treatment)Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment. Percentage of participants with A HBV-DNA Suppression of \< 2,000 IU/mL (Less than 10,000 copies/mL) is reported.
Outcome measures
| Measure |
Peginterferon Alfa-2a 90 μg_24 Weeks
n=142 Participants
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 180 μg_24 Weeks
n=140 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 90 μg_48 Weeks
n=132 Participants
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Peginterferon Alfa-2a 180 μg_48 Weeks
n=130 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment
|
11.27 Percentage of participants
Interval 6.58 to 17.65
|
11.43 Percentage of participants
Interval 6.68 to 17.9
|
22.73 Percentage of participants
Interval 15.89 to 30.83
|
30.0 Percentage of participants
Interval 22.28 to 38.66
|
SECONDARY outcome
Timeframe: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
Combined endpoint was defined as HBeAg seroconversion, a normal serum ALT and HBV-DNA suppression below 20,000 IU/mL.
Outcome measures
| Measure |
Peginterferon Alfa-2a 90 μg_24 Weeks
n=142 Participants
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 180 μg_24 Weeks
n=140 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 90 μg_48 Weeks
n=132 Participants
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Peginterferon Alfa-2a 180 μg_48 Weeks
n=130 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment
|
7.75 Percentage of participants
Interval 3.93 to 13.44
|
15.0 Percentage of participants
Interval 9.53 to 22.01
|
17.42 Percentage of participants
Interval 11.38 to 24.99
|
31.54 Percentage of participants
Interval 23.67 to 40.27
|
SECONDARY outcome
Timeframe: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
Dual endpoint was defined as the achievement of both HBeAg seroconversion and a HBV-DNA \<2,000 IU/ml (Less than 10,000 copies/mL).
Outcome measures
| Measure |
Peginterferon Alfa-2a 90 μg_24 Weeks
n=142 Participants
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 180 μg_24 Weeks
n=140 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 90 μg_48 Weeks
n=132 Participants
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Peginterferon Alfa-2a 180 μg_48 Weeks
n=130 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment
|
7.75 Percentage of participants
Interval 3.93 to 13.44
|
9.29 Percentage of participants
Interval 5.04 to 15.36
|
13.64 Percentage of participants
Interval 8.29 to 20.69
|
24.62 Percentage of participants
Interval 17.49 to 32.94
|
SECONDARY outcome
Timeframe: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)Population: Participants from the Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation who had data available for analysis. Patients were analyzed according to the treatment received. 10 patients in the per-protocol population switched treatment groups for the analysis.
Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay: 0- 55 units/liter (U/L).
Outcome measures
| Measure |
Peginterferon Alfa-2a 90 μg_24 Weeks
n=131 Participants
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 180 μg_24 Weeks
n=133 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 90 μg_48 Weeks
n=126 Participants
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Peginterferon Alfa-2a 180 μg_48 Weeks
n=124 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
|---|---|---|---|---|
|
Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment
|
1.90 U/L
Interval 1.84 to 1.96
|
1.97 U/L
Interval 1.9 to 2.05
|
1.90 U/L
Interval 1.82 to 1.98
|
1.73 U/L
Interval 1.67 to 1.79
|
SECONDARY outcome
Timeframe: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)Population: Participants from the Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation who had data available for analysis. Patients were analyzed according to the treatment received. 10 patients in the per-protocol population switched treatment groups for the analysis.
Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment.
Outcome measures
| Measure |
Peginterferon Alfa-2a 90 μg_24 Weeks
n=128 Participants
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 180 μg_24 Weeks
n=129 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 90 μg_48 Weeks
n=125 Participants
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Peginterferon Alfa-2a 180 μg_48 Weeks
n=124 Participants
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
|---|---|---|---|---|
|
Quantitative HBV-DNA 24 Weeks Following End of Treatment
|
6.33 IU/mL Log10
Interval 5.93 to 6.72
|
6.38 IU/mL Log10
Interval 5.99 to 6.76
|
5.98 IU/mL Log10
Interval 5.51 to 6.45
|
5.29 IU/mL Log10
Interval 4.81 to 5.78
|
Adverse Events
Peginterferon Alfa-2a 90 μg_24 Weeks
Serious events: 4 serious events
Other events: 94 other events
Deaths: 0 deaths
Peginterferon Alfa-2a 180 μg_24 Weeks
Serious events: 4 serious events
Other events: 109 other events
Deaths: 0 deaths
Peginterferon Alfa-2a 90 μg_48 Weeks
Serious events: 6 serious events
Other events: 92 other events
Deaths: 0 deaths
Peginterferon Alfa-2a 180 μg_48 Weeks
Serious events: 5 serious events
Other events: 105 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peginterferon Alfa-2a 90 μg_24 Weeks
n=144 participants at risk
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 180 μg_24 Weeks
n=141 participants at risk
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 90 μg_48 Weeks
n=132 participants at risk
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Peginterferon Alfa-2a 180 μg_48 Weeks
n=130 participants at risk
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Hepatitis B
|
0.69%
1/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.71%
1/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.76%
1/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Infections and infestations
Appendicitis
|
0.69%
1/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.77%
1/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Infections and infestations
Viral infection
|
0.00%
0/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.76%
1/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
1.5%
2/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.77%
1/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.69%
1/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.77%
1/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Immune system disorders
Drug hypersensitivity
|
0.69%
1/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.77%
1/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
0.69%
1/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.76%
1/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.71%
1/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.77%
1/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.76%
1/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
General disorders
Malaise
|
0.00%
0/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.76%
1/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.76%
1/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.71%
1/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.71%
1/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.00%
0/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
Other adverse events
| Measure |
Peginterferon Alfa-2a 90 μg_24 Weeks
n=144 participants at risk
Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 180 μg_24 Weeks
n=141 participants at risk
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
|
Peginterferon Alfa-2a 90 μg_48 Weeks
n=132 participants at risk
Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
Peginterferon Alfa-2a 180 μg_48 Weeks
n=130 participants at risk
Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
|
|---|---|---|---|---|
|
General disorders
Pyrexia
|
27.8%
40/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
35.5%
50/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
32.6%
43/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
35.4%
46/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
General disorders
Fatigue
|
18.8%
27/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
14.2%
20/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
22.0%
29/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
24.6%
32/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
General disorders
Malaise
|
0.69%
1/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
6.4%
9/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
6.1%
8/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
4.6%
6/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.8%
17/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
17.0%
24/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
19.7%
26/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
31.5%
41/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.9%
7/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
5.0%
7/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
3.8%
5/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
8.5%
11/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.5%
5/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
3.5%
5/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
3.0%
4/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
8.5%
11/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.4%
28/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
24.8%
35/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
14.4%
19/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
28.5%
37/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
8/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
4.3%
6/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
4.5%
6/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
6.2%
8/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Nervous system disorders
Headache
|
16.0%
23/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
24.8%
35/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
17.4%
23/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
19.2%
25/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Nervous system disorders
Dizziness
|
3.5%
5/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
5.7%
8/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
3.8%
5/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
7.7%
10/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
4/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
2.8%
4/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
5.3%
7/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
10.8%
14/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
4/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
0.71%
1/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
4.5%
6/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
7.7%
10/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
3/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
3.5%
5/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
2.3%
3/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
6.2%
8/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
8/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
5.0%
7/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
8.3%
11/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
6.2%
8/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
7/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
4.3%
6/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
3.0%
4/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
6.9%
9/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Psychiatric disorders
Insomnia
|
5.6%
8/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
7.8%
11/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
8.3%
11/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
12.3%
16/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.2%
6/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
7.1%
10/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
7.6%
10/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
10.0%
13/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
10/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
6.4%
9/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
2.3%
3/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
2.3%
3/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.1%
3/144
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
1.4%
2/141
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
3.0%
4/132
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
4.6%
6/130
Safety set included randomized patients who received study drug and had at least 1 post-baseline assessment. 1 patient in the PEG-IFN 180 μg 24 week arm had no post-baseline assessments. 10 patients actually received drug for less time and switched arms for analysis (4 PEG-IFN 90 μg 48 weeks to 24 weeks and 6 PEG-IFN 180 μg 48 weeks to 24 weeks.
|
Additional Information
Medical Communications
Hoffman-LaRoche
Phone: 800-821-8590
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