Trial Outcomes & Findings for Efficacy and Safety of Peg-Interferon Alpha-2a Plus Ribavirin in Genotype 1 Chronic Hepatitis C Participants Co-Infected With Human Immunodeficiency Virus (NCT NCT02761629)
NCT ID: NCT02761629
Last Updated: 2016-08-16
Results Overview
SVR was defined as having un-detectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 International Units per milliliter \[IU/mL\]). Participants with detectable HCV RNA or without measurement at the end of the 24 week after completion of study treatment were considered as non-responders.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
180 participants
Primary outcome timeframe
24 weeks after completion of study treatment (up to Week 72 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and up to Week 96 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm)
Results posted on
2016-08-16
Participant Flow
Participant milestones
| Measure |
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
Participants received peg-interferon alpha-2A (Peg-IFN-Alpha-2A) and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 micrograms (mcg) once weekly via subcutaneous injection. Ribavirin was administered as either 1000 milligrams (mg) per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing less than (\<) 75 kilograms (kg) or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing greater than or equal to (\>/=) 75 kg.
|
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kg or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
90
|
|
Overall Study
Treated
|
82
|
86
|
|
Overall Study
COMPLETED
|
63
|
58
|
|
Overall Study
NOT COMPLETED
|
27
|
32
|
Reasons for withdrawal
| Measure |
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
Participants received peg-interferon alpha-2A (Peg-IFN-Alpha-2A) and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 micrograms (mcg) once weekly via subcutaneous injection. Ribavirin was administered as either 1000 milligrams (mg) per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing less than (\<) 75 kilograms (kg) or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing greater than or equal to (\>/=) 75 kg.
|
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kg or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
|---|---|---|
|
Overall Study
Adverse Event/Intercurrent Illness
|
7
|
5
|
|
Overall Study
Insufficient Therapeutic Response
|
2
|
7
|
|
Overall Study
Failure to Return
|
2
|
4
|
|
Overall Study
Did not Cooperate/Refused Treatment
|
2
|
4
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Other
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Randomized But Not Treated
|
8
|
4
|
Baseline Characteristics
Efficacy and Safety of Peg-Interferon Alpha-2a Plus Ribavirin in Genotype 1 Chronic Hepatitis C Participants Co-Infected With Human Immunodeficiency Virus
Baseline characteristics by cohort
| Measure |
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
n=80 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kilograms (kg) or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
n=85 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kg or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
42.2 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
42.3 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after completion of study treatment (up to Week 72 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and up to Week 96 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm)Population: Intent-to-treat (ITT) analysis population
SVR was defined as having un-detectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 International Units per milliliter \[IU/mL\]). Participants with detectable HCV RNA or without measurement at the end of the 24 week after completion of study treatment were considered as non-responders.
Outcome measures
| Measure |
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
n=80 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kilograms (kg) or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
n=85 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kg or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR)
|
23.8 percentage of participants
Interval 15.0 to 34.6
|
36.5 percentage of participants
Interval 26.3 to 47.6
|
SECONDARY outcome
Timeframe: For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Weeks 4, 12, 24, and 48; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Weeks 4, 12, 24, 48, and 72Population: ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and "n" = participants who were evaluable for this outcome at specified time-point; for each arm, respectively.
HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Data for this outcome measure was to be reported up to end of treatment visit (Week 48 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).
Outcome measures
| Measure |
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
n=73 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kilograms (kg) or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
n=83 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kg or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
|---|---|---|
|
Percentage of Participants With Undetectable HCV RNA
Week 4 (n=73, 83)
|
2.7 percentage of participants
Interval 0.3 to 9.6
|
12.0 percentage of participants
Interval 5.9 to 21.0
|
|
Percentage of Participants With Undetectable HCV RNA
Week 12 (n=73, 81)
|
23.3 percentage of participants
Interval 14.2 to 34.7
|
28.4 percentage of participants
Interval 18.9 to 39.5
|
|
Percentage of Participants With Undetectable HCV RNA
Week 24 (n=73, 78)
|
52.1 percentage of participants
Interval 40.0 to 63.9
|
53.8 percentage of participants
Interval 42.2 to 65.2
|
|
Percentage of Participants With Undetectable HCV RNA
Week 48 (n=68, 71)
|
55.9 percentage of participants
Interval 43.3 to 67.9
|
64.8 percentage of participants
Interval 52.5 to 75.8
|
|
Percentage of Participants With Undetectable HCV RNA
Week 72 (n=0, 65)
|
NA percentage of participants
Data for this outcome measure was to be reported up to end of treatment visit (Week 48 for this arm); hence, no data reported for Week 72 for this arm.
|
56.9 percentage of participants
Interval 44.0 to 69.2
|
SECONDARY outcome
Timeframe: 12 weeks after the last dose of Peg-IFN-Alpha-2A (up to Week 60 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and up to Week 84 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm)Population: ITT analysis population
HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Participants with detectable HCV RNA or without measurement at the end of 12 weeks after the last dose of Peg-IFN-Alpha-2A were considered as non-responders.
Outcome measures
| Measure |
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
n=80 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kilograms (kg) or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
n=85 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kg or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
|---|---|---|
|
Percentage of Participants With Undetectable HCV RNA 12 Weeks After the Last Dose of Peg-IFN-Alpha-2A
|
23.8 percentage of participants
Interval 15.0 to 34.6
|
36.5 percentage of participants
Interval 26.3 to 47.6
|
SECONDARY outcome
Timeframe: 24 weeks after completion of study treatment (up to Week 72 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and up to Week 96 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm)Population: ITT analysis population. Here, number of participants analyzed signifies participants with undetectable HCV RNA at the end of treatment.
SVR was defined as having undetectable HCV RNA levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Percentage of participants without SVR among participants with undetectable HCV RNA at the end of treatment was reported (end of treatment = Week 48 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and Week 72 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm).
Outcome measures
| Measure |
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
n=38 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kilograms (kg) or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
n=37 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kg or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
|---|---|---|
|
Percentage of Participants Without SVR Among Participants With Undetectable HCV RNA at the End of Treatment
|
52.6 percentage of participants
|
24.3 percentage of participants
|
SECONDARY outcome
Timeframe: For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Weeks 4, 12, 24, 48, 72, and 96Population: ITT analysis population. Here, number of participants analyzed = participants with detectable HIV RNA levels and "n" = participants with detectable HIV RNA levels at specified time-point; for each arm, respectively.
HIV RNA levels were measured using Roche AMPLICOR MONITOR HIV-1 Test (limit of detection: 400 HIV-1 RNA copies/mL). Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).
Outcome measures
| Measure |
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
n=12 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kilograms (kg) or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
n=23 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kg or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
|---|---|---|
|
Serum Human Immunodeficiency Virus (HIV) RNA Levels
Baseline (n=12, 23)
|
4.23 Log10 copies per milliliter
Standard Deviation 0.82
|
4.64 Log10 copies per milliliter
Standard Deviation 0.74
|
|
Serum Human Immunodeficiency Virus (HIV) RNA Levels
Week 4 (n=6, 16)
|
3.94 Log10 copies per milliliter
Standard Deviation 0.38
|
3.98 Log10 copies per milliliter
Standard Deviation 0.69
|
|
Serum Human Immunodeficiency Virus (HIV) RNA Levels
Week 24 (n=9, 20)
|
3.96 Log10 copies per milliliter
Standard Deviation 0.36
|
4.21 Log10 copies per milliliter
Standard Deviation 0.72
|
|
Serum Human Immunodeficiency Virus (HIV) RNA Levels
Week 48 (n=11, 17)
|
4.02 Log10 copies per milliliter
Standard Deviation 0.65
|
4.41 Log10 copies per milliliter
Standard Deviation 0.75
|
|
Serum Human Immunodeficiency Virus (HIV) RNA Levels
Week 72 (n=10, 9)
|
4.08 Log10 copies per milliliter
Standard Deviation 0.78
|
4.51 Log10 copies per milliliter
Standard Deviation 0.85
|
|
Serum Human Immunodeficiency Virus (HIV) RNA Levels
Week 96 (n=0, 13)
|
NA Log10 copies per milliliter
Standard Deviation NA
Data for this outcome measure was to be reported up to 24 weeks after end of treatment (Week 72 for this arm); hence, no data reported for Week 96 for this arm.
|
4.22 Log10 copies per milliliter
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96Population: ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and "n" = participants who were evaluable at specified time-point; for each arm, respectively.
Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).
Outcome measures
| Measure |
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
n=78 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kilograms (kg) or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
n=81 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kg or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
|---|---|---|
|
Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96
Baseline (n=78, 81)
|
578.7 Cells per cubic millimeter (cells/mm^3)
Standard Deviation 277.1
|
546.2 Cells per cubic millimeter (cells/mm^3)
Standard Deviation 278.8
|
|
Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96
Change at Week 4 (n=69, 74)
|
-148.2 Cells per cubic millimeter (cells/mm^3)
Standard Deviation 197.5
|
-88.0 Cells per cubic millimeter (cells/mm^3)
Standard Deviation 154.9
|
|
Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96
Change at Week 12 (n=68, 75)
|
-185.4 Cells per cubic millimeter (cells/mm^3)
Standard Deviation 192.7
|
-164.5 Cells per cubic millimeter (cells/mm^3)
Standard Deviation 193.9
|
|
Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96
Change at Week 24 (n=69, 68)
|
-206.7 Cells per cubic millimeter (cells/mm^3)
Standard Deviation 217.0
|
-178.4 Cells per cubic millimeter (cells/mm^3)
Standard Deviation 207.5
|
|
Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96
Change at Week 48 (n=61, 67)
|
-209.4 Cells per cubic millimeter (cells/mm^3)
Standard Deviation 242.4
|
-196.4 Cells per cubic millimeter (cells/mm^3)
Standard Deviation 226.4
|
|
Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96
Change at Week 72 (n=58, 55)
|
9.5 Cells per cubic millimeter (cells/mm^3)
Standard Deviation 188.9
|
-167.5 Cells per cubic millimeter (cells/mm^3)
Standard Deviation 235.8
|
|
Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96
Change at Week 96 (n=0, 62)
|
NA Cells per cubic millimeter (cells/mm^3)
Standard Deviation NA
Data for this outcome measure was to be reported up to 24 weeks after end of treatment (Week 72 for this arm); hence, no data reported for Week 96 for this arm.
|
-15.1 Cells per cubic millimeter (cells/mm^3)
Standard Deviation 212.2
|
SECONDARY outcome
Timeframe: For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96Population: ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and "n" = participants who were evaluable at specified time-point; for each arm, respectively.
Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).
Outcome measures
| Measure |
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
n=78 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kilograms (kg) or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
n=81 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kg or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
|---|---|---|
|
Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96
Change at Week 72 (n=58, 55)
|
0.12 Ratio
Standard Deviation 0.41
|
0.36 Ratio
Standard Deviation 0.43
|
|
Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96
Change at Week 96 (n=0, 62)
|
NA Ratio
Standard Deviation NA
Data for this outcome measure was to be reported up to 24 weeks after end of treatment (Week 72 for this arm); hence, no data reported for Week 96 for this arm.
|
0.09 Ratio
Standard Deviation 0.35
|
|
Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96
Baseline (n=78, 81)
|
0.67 Ratio
Standard Deviation 0.39
|
0.68 Ratio
Standard Deviation 0.44
|
|
Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96
Change at Week 4 (n=69, 74)
|
0.11 Ratio
Standard Deviation 0.42
|
0.09 Ratio
Standard Deviation 0.21
|
|
Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96
Change at Week 12 (n=68, 75)
|
0.22 Ratio
Standard Deviation 0.31
|
0.20 Ratio
Standard Deviation 0.27
|
|
Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96
Change at Week 24 (n=69, 68)
|
0.36 Ratio
Standard Deviation 0.51
|
0.29 Ratio
Standard Deviation 0.30
|
|
Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96
Change at Week 48 (n=61, 67)
|
0.43 Ratio
Standard Deviation 0.47
|
0.30 Ratio
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Weeks 4, 12, 24, 48, 72, and 96Population: Safety analysis population: all randomized participants who receive \>/=1 dose of any study medication and had \>/=1 post-baseline safety assessment. Number of participants analyzed= overall participants who were evaluable for this outcome at any time-point and "n" = participants who were evaluable at specified time-point; for each arm, respectively.
ALT levels were classified as: Normal Limit (NL) (as per laboratory standard), \>1-2 Upper Normal Limit (ULN), \>2-5 ULN, \>5-10 ULN, and \>10 ULN. Percentage of participants in each of these ALT level categories was reported. Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).
Outcome measures
| Measure |
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
n=79 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kilograms (kg) or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
n=82 Participants
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kg or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
|---|---|---|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 48, >2-5 ULN (n=65, 71)
|
7.7 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 72, >1-2 ULN (n=59, 61)
|
27.1 percentage of participants
|
27.9 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 72, >2-5 ULN (n=59, 61)
|
20.3 percentage of participants
|
3.3 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 72, >5-10 ULN (n=59, 61)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 96, NL (n=0, 62)
|
NA percentage of participants
Data for this outcome measure was to be reported up to 24 weeks after end of treatment (Week 72 for this arm); hence, no data reported for Week 96 for this arm.
|
50.0 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 96, >1-2 ULN (n=0, 62)
|
NA percentage of participants
Data for this outcome measure was to be reported up to 24 weeks after end of treatment (Week 72 for this arm); hence, no data reported for Week 96 for this arm.
|
35.5 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 96, >2-5 ULN (n=0, 62)
|
NA percentage of participants
Data for this outcome measure was to be reported up to 24 weeks after end of treatment (Week 72 for this arm); hence, no data reported for Week 96 for this arm.
|
12.9 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 96, >5-10 ULN (n=0, 62)
|
NA percentage of participants
Data for this outcome measure was to be reported up to 24 weeks after end of treatment (Week 72 for this arm); hence, no data reported for Week 96 for this arm.
|
1.6 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 96, >10 ULN (n=0, 62)
|
NA percentage of participants
Data for this outcome measure was to be reported up to 24 weeks after end of treatment (Week 72 for this arm); hence, no data reported for Week 96 for this arm.
|
0.0 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 4, NL (n=70, 78)
|
50.0 percentage of participants
|
52.6 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 4, >1-2 ULN (n=70, 78)
|
40.0 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 4, >2-5 ULN (n=70, 78)
|
10.0 percentage of participants
|
9.0 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 4, >5-10 ULN (n=70, 78)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 4, >10 ULN (n=70, 78)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 12, NL (n=76, 77)
|
61.8 percentage of participants
|
62.3 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 12, >1-2 ULN (n=76, 77)
|
27.6 percentage of participants
|
29.9 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 12, >2-5 ULN (n=76, 77)
|
10.5 percentage of participants
|
5.2 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 12, >5-10 ULN (n=76, 77)
|
0.0 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 12, >10 ULN (n=76, 77)
|
0.0 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 24, NL (n=74, 74)
|
70.3 percentage of participants
|
63.5 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 24, >1-2 ULN (n=74, 74)
|
27.0 percentage of participants
|
28.4 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 24, >2-5 ULN (n=74, 74)
|
2.7 percentage of participants
|
6.8 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 24, >5-10 ULN (n=74, 74)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 24, >10 ULN (n=74, 74)
|
0.0 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 48, NL (n=65, 71)
|
67.7 percentage of participants
|
69.0 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 48, >1-2 ULN (n=65, 71)
|
24.6 percentage of participants
|
26.8 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 48, >5-10 ULN (n=65, 71)
|
0.0 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 48, >10 ULN (n=65, 71)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 72, NL (n=59, 61)
|
52.5 percentage of participants
|
68.9 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Week 72, >10 ULN (n=59, 61)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
Serious events: 7 serious events
Other events: 79 other events
Deaths: 0 deaths
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Serious events: 12 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
n=82 participants at risk
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kilograms (kg) or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
n=86 participants at risk
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kg or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
|---|---|---|
|
Infections and infestations
Pneumonia NOS
|
1.2%
1/82 • 96 weeks
Safety analysis population.
|
0.00%
0/86 • 96 weeks
Safety analysis population.
|
|
Infections and infestations
Postoperative infection
|
1.2%
1/82 • 96 weeks
Safety analysis population.
|
0.00%
0/86 • 96 weeks
Safety analysis population.
|
|
Infections and infestations
Respiratory tract infection NOS
|
1.2%
1/82 • 96 weeks
Safety analysis population.
|
1.2%
1/86 • 96 weeks
Safety analysis population.
|
|
Infections and infestations
Cytomegalovirus oesophagitis
|
0.00%
0/82 • 96 weeks
Safety analysis population.
|
1.2%
1/86 • 96 weeks
Safety analysis population.
|
|
Infections and infestations
Furuncle
|
0.00%
0/82 • 96 weeks
Safety analysis population.
|
1.2%
1/86 • 96 weeks
Safety analysis population.
|
|
Infections and infestations
Mycobacterial infection NOS
|
0.00%
0/82 • 96 weeks
Safety analysis population.
|
1.2%
1/86 • 96 weeks
Safety analysis population.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
1.2%
1/82 • 96 weeks
Safety analysis population.
|
0.00%
0/86 • 96 weeks
Safety analysis population.
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.2%
1/82 • 96 weeks
Safety analysis population.
|
0.00%
0/86 • 96 weeks
Safety analysis population.
|
|
Endocrine disorders
Hypothyroidism
|
1.2%
1/82 • 96 weeks
Safety analysis population.
|
0.00%
0/86 • 96 weeks
Safety analysis population.
|
|
General disorders
Influenza like illness
|
1.2%
1/82 • 96 weeks
Safety analysis population.
|
0.00%
0/86 • 96 weeks
Safety analysis population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer NOS
|
1.2%
1/82 • 96 weeks
Safety analysis population.
|
0.00%
0/86 • 96 weeks
Safety analysis population.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy NOS
|
1.2%
1/82 • 96 weeks
Safety analysis population.
|
0.00%
0/86 • 96 weeks
Safety analysis population.
|
|
Psychiatric disorders
Depression
|
1.2%
1/82 • 96 weeks
Safety analysis population.
|
0.00%
0/86 • 96 weeks
Safety analysis population.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/82 • 96 weeks
Safety analysis population.
|
1.2%
1/86 • 96 weeks
Safety analysis population.
|
|
Renal and urinary disorders
Renal failure acute
|
1.2%
1/82 • 96 weeks
Safety analysis population.
|
0.00%
0/86 • 96 weeks
Safety analysis population.
|
|
Blood and lymphatic system disorders
Anaemia not otherwise specified (NOS)
|
0.00%
0/82 • 96 weeks
Safety analysis population.
|
1.2%
1/86 • 96 weeks
Safety analysis population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/82 • 96 weeks
Safety analysis population.
|
1.2%
1/86 • 96 weeks
Safety analysis population.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/82 • 96 weeks
Safety analysis population.
|
1.2%
1/86 • 96 weeks
Safety analysis population.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/82 • 96 weeks
Safety analysis population.
|
1.2%
1/86 • 96 weeks
Safety analysis population.
|
|
Hepatobiliary disorders
Cholecystitis NOS
|
0.00%
0/82 • 96 weeks
Safety analysis population.
|
1.2%
1/86 • 96 weeks
Safety analysis population.
|
|
Hepatobiliary disorders
Hepatic disorder NOS
|
0.00%
0/82 • 96 weeks
Safety analysis population.
|
1.2%
1/86 • 96 weeks
Safety analysis population.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/82 • 96 weeks
Safety analysis population.
|
1.2%
1/86 • 96 weeks
Safety analysis population.
|
|
Reproductive system and breast disorders
Vulvar dysplasia
|
0.00%
0/82 • 96 weeks
Safety analysis population.
|
1.2%
1/86 • 96 weeks
Safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/82 • 96 weeks
Safety analysis population.
|
1.2%
1/86 • 96 weeks
Safety analysis population.
|
|
Social circumstances
Drug abuser NOS
|
0.00%
0/82 • 96 weeks
Safety analysis population.
|
1.2%
1/86 • 96 weeks
Safety analysis population.
|
Other adverse events
| Measure |
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
n=82 participants at risk
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kilograms (kg) or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
n=86 participants at risk
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \<75 kg or as 1200 mg per day (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing \>/=75 kg.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia NOS
|
37.8%
31/82 • 96 weeks
Safety analysis population.
|
29.1%
25/86 • 96 weeks
Safety analysis population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.9%
13/82 • 96 weeks
Safety analysis population.
|
16.3%
14/86 • 96 weeks
Safety analysis population.
|
|
Gastrointestinal disorders
Nausea
|
25.6%
21/82 • 96 weeks
Safety analysis population.
|
23.3%
20/86 • 96 weeks
Safety analysis population.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
15.9%
13/82 • 96 weeks
Safety analysis population.
|
18.6%
16/86 • 96 weeks
Safety analysis population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.2%
10/82 • 96 weeks
Safety analysis population.
|
9.3%
8/86 • 96 weeks
Safety analysis population.
|
|
Gastrointestinal disorders
Vomiting NOS
|
11.0%
9/82 • 96 weeks
Safety analysis population.
|
19.8%
17/86 • 96 weeks
Safety analysis population.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
5/82 • 96 weeks
Safety analysis population.
|
8.1%
7/86 • 96 weeks
Safety analysis population.
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
4.9%
4/82 • 96 weeks
Safety analysis population.
|
10.5%
9/86 • 96 weeks
Safety analysis population.
|
|
General disorders
Pyrexia
|
36.6%
30/82 • 96 weeks
Safety analysis population.
|
37.2%
32/86 • 96 weeks
Safety analysis population.
|
|
General disorders
Fatigue
|
31.7%
26/82 • 96 weeks
Safety analysis population.
|
31.4%
27/86 • 96 weeks
Safety analysis population.
|
|
General disorders
Asthenia
|
28.0%
23/82 • 96 weeks
Safety analysis population.
|
34.9%
30/86 • 96 weeks
Safety analysis population.
|
|
General disorders
Influenza like illness
|
15.9%
13/82 • 96 weeks
Safety analysis population.
|
14.0%
12/86 • 96 weeks
Safety analysis population.
|
|
General disorders
Malaise
|
12.2%
10/82 • 96 weeks
Safety analysis population.
|
9.3%
8/86 • 96 weeks
Safety analysis population.
|
|
General disorders
Chest pain
|
9.8%
8/82 • 96 weeks
Safety analysis population.
|
7.0%
6/86 • 96 weeks
Safety analysis population.
|
|
Infections and infestations
Influenza
|
7.3%
6/82 • 96 weeks
Safety analysis population.
|
8.1%
7/86 • 96 weeks
Safety analysis population.
|
|
Infections and infestations
Sinusitis NOS
|
7.3%
6/82 • 96 weeks
Safety analysis population.
|
8.1%
7/86 • 96 weeks
Safety analysis population.
|
|
Infections and infestations
Herpes simplex
|
6.1%
5/82 • 96 weeks
Safety analysis population.
|
3.5%
3/86 • 96 weeks
Safety analysis population.
|
|
Infections and infestations
Oral candidiasis
|
4.9%
4/82 • 96 weeks
Safety analysis population.
|
5.8%
5/86 • 96 weeks
Safety analysis population.
|
|
Investigations
Weight decreased
|
11.0%
9/82 • 96 weeks
Safety analysis population.
|
9.3%
8/86 • 96 weeks
Safety analysis population.
|
|
Metabolism and nutrition disorders
Anorexia
|
30.5%
25/82 • 96 weeks
Safety analysis population.
|
25.6%
22/86 • 96 weeks
Safety analysis population.
|
|
Metabolism and nutrition disorders
Appetite decreased NOS
|
11.0%
9/82 • 96 weeks
Safety analysis population.
|
16.3%
14/86 • 96 weeks
Safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
46.3%
38/82 • 96 weeks
Safety analysis population.
|
38.4%
33/86 • 96 weeks
Safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.5%
7/82 • 96 weeks
Safety analysis population.
|
15.1%
13/86 • 96 weeks
Safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
5/82 • 96 weeks
Safety analysis population.
|
10.5%
9/86 • 96 weeks
Safety analysis population.
|
|
Nervous system disorders
Headache
|
41.5%
34/82 • 96 weeks
Safety analysis population.
|
47.7%
41/86 • 96 weeks
Safety analysis population.
|
|
Nervous system disorders
Dizziness
|
17.1%
14/82 • 96 weeks
Safety analysis population.
|
9.3%
8/86 • 96 weeks
Safety analysis population.
|
|
Nervous system disorders
Somnolence
|
7.3%
6/82 • 96 weeks
Safety analysis population.
|
9.3%
8/86 • 96 weeks
Safety analysis population.
|
|
Psychiatric disorders
Depression
|
19.5%
16/82 • 96 weeks
Safety analysis population.
|
12.8%
11/86 • 96 weeks
Safety analysis population.
|
|
Psychiatric disorders
Irritability
|
18.3%
15/82 • 96 weeks
Safety analysis population.
|
15.1%
13/86 • 96 weeks
Safety analysis population.
|
|
Psychiatric disorders
Insomnia
|
17.1%
14/82 • 96 weeks
Safety analysis population.
|
26.7%
23/86 • 96 weeks
Safety analysis population.
|
|
Psychiatric disorders
Anxiety
|
9.8%
8/82 • 96 weeks
Safety analysis population.
|
10.5%
9/86 • 96 weeks
Safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
6/82 • 96 weeks
Safety analysis population.
|
17.4%
15/86 • 96 weeks
Safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.1%
5/82 • 96 weeks
Safety analysis population.
|
3.5%
3/86 • 96 weeks
Safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.7%
3/82 • 96 weeks
Safety analysis population.
|
5.8%
5/86 • 96 weeks
Safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.0%
9/82 • 96 weeks
Safety analysis population.
|
10.5%
9/86 • 96 weeks
Safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.3%
6/82 • 96 weeks
Safety analysis population.
|
12.8%
11/86 • 96 weeks
Safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.2%
1/82 • 96 weeks
Safety analysis population.
|
7.0%
6/86 • 96 weeks
Safety analysis 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