Trial Outcomes & Findings for A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC). (NCT NCT00077649)
NCT ID: NCT00077649
Last Updated: 2016-04-18
Results Overview
Viral loads (quantitative HCV RNA) collected during the initial 24 weeks were first logarithmically (based 10) transformed. Results falling below the assay sensitivity level were set to the assay sensitivity level before the analyses. Thus, a qualitative HCV RNA negative result was set to 50 IU/mL (or 100 copies/mL). A qualitative HCV RNA positive result along with an unquantifiable HCV RNA result from the quantitative assay corresponded to a numeric HCV RNA result of 600 IU/mL (or 1000 copies/mL).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
188 participants
Primary outcome timeframe
Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24
Results posted on
2016-04-18
Participant Flow
A total of 188 participants were enrolled in the study which was conducted at 23 centers in the United States from 13 January 2004 to 06 December 2005
Number of participants who completed and did not complete the 48 weeks of treatment are presented in the table .
Participant milestones
| Measure |
PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg
Participants received 180 micrograms (mcg) of PEG-IFN \[peginterferon\] alfa-2a in 1 milliliter (mL) solution administered subcutaneously (SC), once weekly + 1200 milligrams (mg) of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered \[orally \] po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
47
|
47
|
47
|
|
Overall Study
Completed 24 Weeks of Follow-up
|
36
|
40
|
36
|
31
|
|
Overall Study
COMPLETED
|
33
|
38
|
32
|
30
|
|
Overall Study
NOT COMPLETED
|
14
|
9
|
15
|
17
|
Reasons for withdrawal
| Measure |
PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg
Participants received 180 micrograms (mcg) of PEG-IFN \[peginterferon\] alfa-2a in 1 milliliter (mL) solution administered subcutaneously (SC), once weekly + 1200 milligrams (mg) of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered \[orally \] po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
7
|
9
|
|
Overall Study
Lack of Efficacy
|
5
|
3
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
3
|
2
|
|
Overall Study
Abnormality of Laboratory Test
|
1
|
2
|
1
|
2
|
|
Overall Study
Randomized but never dosed
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).
Baseline characteristics by cohort
| Measure |
PEG-IFN Alfa-2a 180 mcg+ Ribavirin 1200 mg
n=47 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered \[orally \] po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 7.48 • n=5 Participants
|
49.6 years
STANDARD_DEVIATION 8.46 • n=7 Participants
|
47.1 years
STANDARD_DEVIATION 6.37 • n=5 Participants
|
48.5 years
STANDARD_DEVIATION 6.78 • n=4 Participants
|
48.1 years
STANDARD_DEVIATION 7.33 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
151 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24Population: The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.
Viral loads (quantitative HCV RNA) collected during the initial 24 weeks were first logarithmically (based 10) transformed. Results falling below the assay sensitivity level were set to the assay sensitivity level before the analyses. Thus, a qualitative HCV RNA negative result was set to 50 IU/mL (or 100 copies/mL). A qualitative HCV RNA positive result along with an unquantifiable HCV RNA result from the quantitative assay corresponded to a numeric HCV RNA result of 600 IU/mL (or 1000 copies/mL).
Outcome measures
| Measure |
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg
n=46 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
|---|---|---|---|---|
|
HCV RNA Profile During The First 24 Weeks
At Week 24, (n=42,45,40,37)
|
2.21 log 10 copies/mL
Standard Deviation 1.32
|
2.76 log 10 copies/mL
Standard Deviation 1.59
|
2.82 log 10 copies/mL
Standard Deviation 1.58
|
2.25 log 10 copies/mL
Standard Deviation 1.10
|
|
HCV RNA Profile During The First 24 Weeks
Baseline, (n=46,47,47,47)
|
6.53 log 10 copies/mL
Standard Deviation 0.42
|
6.50 log 10 copies/mL
Standard Deviation 0.45
|
6.61 log 10 copies/mL
Standard Deviation 0.41
|
6.55 log 10 copies/mL
Standard Deviation 0.44
|
|
HCV RNA Profile During The First 24 Weeks
At Hour 72, (n=41,41,42,46)
|
5.49 log 10 copies/mL
Standard Deviation 0.90
|
5.80 log 10 copies/mL
Standard Deviation 0.54
|
5.82 log 10 copies/mL
Standard Deviation 0.84
|
5.52 log 10 copies/mL
Standard Deviation 0.67
|
|
HCV RNA Profile During The First 24 Weeks
At Week 1, (n=44,47,45,46)
|
5.45 log 10 copies/mL
Standard Deviation 0.97
|
5.74 log 10 copies/mL
Standard Deviation 0.58
|
5.81 log 10 copies/mL
Standard Deviation 0.92
|
5.42 log 10 copies/mL
Standard Deviation 0.84
|
|
HCV RNA Profile During The First 24 Weeks
At Week 2, (n=43,45,43,46)
|
4.84 log 10 copies/mL
Standard Deviation 1.27
|
5.32 log 10 copies/mL
Standard Deviation 0.91
|
5.37 log 10 copies/mL
Standard Deviation 1.20
|
4.83 log 10 copies/mL
Standard Deviation 1.12
|
|
HCV RNA Profile During The First 24 Weeks
At Week 4, (n=44,45,44,46)
|
3.85 log 10 copies/mL
Standard Deviation 1.41
|
4.35 log 10 copies/mL
Standard Deviation 1.32
|
4.62 log 10 copies/mL
Standard Deviation 1.38
|
3.94 log 10 copies/mL
Standard Deviation 1.36
|
|
HCV RNA Profile During The First 24 Weeks
At Week 12, (n=45,45,41,44)
|
2.75 log 10 copies/mL
Standard Deviation 1.57
|
2.99 log 10 copies/mL
Standard Deviation 1.55
|
3.10 log 10 copies/mL
Standard Deviation 1.53
|
2.52 log 10 copies/mL
Standard Deviation 1.28
|
PRIMARY outcome
Timeframe: 72 hours post-dose, Weeks 1, 2, 4, 12, and 24Population: The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.
Virological response over time to Week 24 is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, V. 2.0 (detection limit = 50 IU/mL) at 72 hours and at weeks 1, 2, 12, and 24.
Outcome measures
| Measure |
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg
n=46 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Virological Response Over Time to Week 24
At Hour 72
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Virological Response Over Time to Week 24
At Week 1
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Virological Response Over Time to Week 24
At Week 2
|
2.1 percentage of participants
Interval 0.0 to 6.25
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
2.1 percentage of participants
Interval 0.0 to 6.25
|
2.1 percentage of participants
Interval 0.0 to 6.25
|
|
Percentage of Participants With Virological Response Over Time to Week 24
At Week 4
|
12.8 percentage of participants
Interval 3.23 to 22.31
|
2.2 percentage of participants
Interval 0.0 to 6.39
|
8.5 percentage of participants
Interval 0.53 to 16.49
|
10.6 percentage of participants
Interval 1.82 to 19.45
|
|
Percentage of Participants With Virological Response Over Time to Week 24
At Week 12
|
51.1 percentage of participants
Interval 36.77 to 65.36
|
47.8 percentage of participants
Interval 33.39 to 62.26
|
38.3 percentage of participants
Interval 24.4 to 52.2
|
53.2 percentage of participants
Interval 38.93 to 67.46
|
|
Percentage of Participants With Virological Response Over Time to Week 24
At Week 24
|
68.1 percentage of participants
Interval 54.76 to 81.41
|
56.5 percentage of participants
Interval 42.2 to 70.85
|
55.3 percentage of participants
Interval 41.11 to 69.53
|
59.6 percentage of participants
Interval 45.54 to 73.6
|
PRIMARY outcome
Timeframe: Week 4 and 12Population: The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.
The predicted sustained virological response (SVR) for each treatment group, is determined using a model based on the log10-transformed HCV viral load in copies/mL at Week 4 and the virological response status at Week 12. Each participant was classified as a predicted SVR if p was ≥ 0.5 or as a non-SVR if p was \<0.5. The percentage was calculated from the number of participant (N) analyzed under "Distribution of the predicted probability of an SVR."
Outcome measures
| Measure |
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
n=46 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg
n=44 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg
n=45 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg
n=44 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Predicted Sustained Virological Response
|
50.0 percentage of participants
|
40.9 percentage of participants
|
31.1 percentage of participants
|
47.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 72Population: The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.
SVR is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/ml) at the end of the 24-week untreated follow-up period.
Outcome measures
| Measure |
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg
n=46 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virological Response
|
46.8 percentage of participants
Interval 32.54 to 61.07
|
28.3 percentage of participants
Interval 15.25 to 41.27
|
31.9 percentage of participants
Interval 18.59 to 45.24
|
36.2 percentage of participants
Interval 22.43 to 49.91
|
SECONDARY outcome
Timeframe: Week 48Population: The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.
Virological response at the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at the completion of the treatment period.
Outcome measures
| Measure |
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg
n=46 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Virological Response at the End of the Treatment Period
|
55.3 percentage of participants
Interval 41.11 to 69.53
|
45.7 percentage of participants
Interval 31.26 to 60.05
|
57.4 percentage of participants
Interval 43.31 to 71.58
|
55.3 percentage of participants
Interval 41.11 to 69.53
|
SECONDARY outcome
Timeframe: Week 60Population: The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.
Virological response at 12 weeks after the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at 12 weeks after completion of the treatment period.
Outcome measures
| Measure |
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg
n=46 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period
|
46.8 percentage of participants
Interval 32.54 to 61.07
|
28.3 percentage of participants
Interval 15.25 to 41.27
|
29.8 percentage of participants
Interval 16.71 to 42.86
|
34.0 percentage of participants
Interval 20.5 to 47.59
|
SECONDARY outcome
Timeframe: Up to Week 72Population: The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis. .
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is any adverse event (SAE) that can result in death or is Life-threatening or required in-patient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Outcome measures
| Measure |
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg
n=46 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events and Serious Adverse Events
Any AE
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Adverse Events and Serious Adverse Events
SAE
|
11 percentage of participants
|
9 percentage of participants
|
13 percentage of participants
|
13 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 60Population: The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment where included in the analysis. .
Marked laboratory abnormalities are the values outside the roche defined reference range.It is hemoglobin 11.0 - 20.0 (g/dL),platelets 100 - 700 (10\^9/L), lymphocyte 1.00 - 6.30 (10\^9/L),neutrophils 1.50 or more (10\^9/L), white blood cells(WBC) 3.0 - 18.0 (10\^9/L),serum glutamic-pyruvic transaminase (SGPT) 0 - 60 (U/L), serum glutamic oxaloacetic transaminase (SGOT) 0 - 50 (U/L), alkaline phosphatase 0 - 190 (U/L),albumin was 27.0 or more (g/L),gamma glutamyl transferases (GGT) 0 - 120 (U/L),Total protein 55 - 87 (g/L),total bilirubin 0 - 34.2 (μmol/L),BUN 0 - 14.3 (mmol/L),creatinine 0 - 154 (μmol/L),chloride 95 - 115 (mmol/L),potassium 3.0 - 6.0 (mmol/L), sodium 130 - 150 (mmol/L),thyroid stimulating hormone (TSH) 0.0 - 10.0 (mU/L),triglycerides 0.00 - 2.83 (mmol/L), calcium 2.00 - 2.90 (mmol/L),phosphate 0.75 - 1.60 (mmol/L),Blood Glucose 2.80 - 11.10 (mmol/L),Uric Acid 0 - 600 (μmol/L),proteinuria 0 - 1 (0 to 4+), glycosuria 0 - 1 (0 to 4+), hematuria 0 - 1 (0 to 4+).
Outcome measures
| Measure |
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg
n=45 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg
n=46 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Marked Laboratory Abnormalities
Hematocrit (fraction) Low, (n=45,47,46,47)
|
64 percentage of participants
|
44 percentage of participants
|
53 percentage of participants
|
41 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Hemoglobin (g/dl) - Low, (n= 45,47,46,47)
|
55 percentage of participants
|
42 percentage of participants
|
57 percentage of participants
|
48 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Platelets Low, (n= 45,47,46,47)
|
21 percentage of participants
|
27 percentage of participants
|
26 percentage of participants
|
28 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
WBC - High, [n= 45,47,46,47]
|
0 percentage of participants
|
0 percentage of participants
|
2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
WBC - Low, (n= 45,47,46,47)
|
74 percentage of participants
|
76 percentage of participants
|
72 percentage of participants
|
70 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Lymphocytes High, (n= 45,47,46,47)
|
2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Lymphocytes Low (n= 45,47,46,47)
|
72 percentage of participants
|
73 percentage of participants
|
68 percentage of participants
|
72 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Neutrophils Low, (n= 45,47,46,47)
|
74 percentage of participants
|
82 percentage of participants
|
79 percentage of participants
|
74 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
SGPT High, (n= 45,47,46,47)
|
13 percentage of participants
|
20 percentage of participants
|
19 percentage of participants
|
15 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Albumin Low, (n= 45,47,46,47)
|
2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Alkaline Phosphate High, (n= 45,47,46,47)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
SGOT High, (n= 45,47,46,47)
|
26 percentage of participants
|
16 percentage of participants
|
17 percentage of participants
|
22 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
GGT High, (n= 45,47,46,47)
|
19 percentage of participants
|
27 percentage of participants
|
19 percentage of participants
|
15 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Total Bilirubin High, (n= 45,47,46,47)
|
2 percentage of participants
|
9 percentage of participants
|
6 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Total Protein High, (n= 45,47,46,47)
|
4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Bun High, (n= 45,47,46,47)
|
0 percentage of participants
|
0 percentage of participants
|
2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Chloride High, (n= 45,47,46,47)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Chloride Low (n= 45,47,46,47)
|
2 percentage of participants
|
0 percentage of participants
|
2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Creatinine High, (n= 45,47,46,47)
|
0 percentage of participants
|
0 percentage of participants
|
2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Potassium Low, (n= 45,47,46,47)
|
0 percentage of participants
|
0 percentage of participants
|
2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Sodium High, (n= 45,47,46,47)
|
2 percentage of participants
|
2 percentage of participants
|
4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Sodium Low, (n= 45,47,46,47)
|
2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
TSH High, (n= 45,46,43,46)
|
9 percentage of participants
|
0 percentage of participants
|
7 percentage of participants
|
5 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Calcium Low, (n= 45,47,46,47)
|
2 percentage of participants
|
0 percentage of participants
|
4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Phosphate High, (n= 45,47,46,47)
|
0 percentage of participants
|
2 percentage of participants
|
0 percentage of participants
|
7 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Phosphate Low, (n= 45,47,46,47)
|
30 percentage of participants
|
31 percentage of participants
|
36 percentage of participants
|
20 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Random glucose High, (n= 45,47,46,47)
|
6 percentage of participants
|
2 percentage of participants
|
11 percentage of participants
|
4 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Triglycerides High, (n= 45,47,46,47)
|
49 percentage of participants
|
60 percentage of participants
|
38 percentage of participants
|
57 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Uric acid High (n= 45,47,46,47)
|
15 percentage of participants
|
9 percentage of participants
|
11 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Glycosuria High, (n= 44,46,44,45)
|
2 percentage of participants
|
7 percentage of participants
|
0 percentage of participants
|
5 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Hematuria High, (n= 44,46,44,45)
|
0 percentage of participants
|
5 percentage of participants
|
2 percentage of participants
|
7 percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Proteinuria High, (n= 44,46,44,45)
|
0 percentage of participants
|
2 percentage of participants
|
2 percentage of participants
|
5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 72Population: The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis. .
Vital signs (Systolic blood pressure, Diastolic blood pressure, Pulse rate) were considered to be abnormal and of potential clinical relevance if the values measured for these parameters represented a change from baseline of greater than 20% in the direction of worsening. High diastolic blood pressure is defined as \>110 mmhg and \>20% increase from baseline. High systolic blood pressure is defined as \>180 mmhg and \>20% increase from baseline. Low systolic blood pressure is defined as \<85 mmhg and \>20% decrease from baseline. High heart rate is defined as \>120 beats/minute and \>20% increase from baseline. Low heart rate is defined as \< 50 beats/minute and \>20% decrease from baseline.
Outcome measures
| Measure |
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg
n=45 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg
n=46 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Abnormal Vital Signs
Diastolic BP, High (n=45,47,46,47)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Vital Signs
Systolic BP High, (n=45,47,46,47)
|
4 percentage of participants
|
0 percentage of participants
|
2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Vital Signs
Systolic BP Low, (n=45,47,46,47)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With Abnormal Vital Signs
Heart Rate Low, (n=45,47,46,47)
|
0 percentage of participants
|
2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Vital Signs
Heart Rate, High, (n=45,47,46,47)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Week 72Population: The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis.
The BDI-II is a self-reported assessment of 21 items which included sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, loss of interest in sex that are summarized by treatment group. All except two items had four statements that were scored on a scale ranging from 0 to 3. The maximum total score was 63. The scores for each item were summed to obtain the total for that assessment. The participants neurological status could then be categorized as follows: minimal depression: 0 to 13; mild depression: 14 to 19; moderate depression: 20 to 28; and severe depression: 29 to 63. The BDI-II questionnaire was self-administered by the patient at each visit.
Outcome measures
| Measure |
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg
n=46 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg
n=47 Participants
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg
n=47 Participants
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
|---|---|---|---|---|
|
Total BDI-II (Beck Depression Inventory) Scores
Baseline, n=46,46,47,46
|
4.43 Units on a scale
Standard Deviation 4.70
|
3.52 Units on a scale
Standard Deviation 4.34
|
4.39 Units on a scale
Standard Deviation 4.82
|
4.23 Units on a scale
Standard Deviation 4.31
|
|
Total BDI-II (Beck Depression Inventory) Scores
Week 1, (n=43,44,43,45)
|
3.96 Units on a scale
Standard Deviation 3.76
|
4.24 Units on a scale
Standard Deviation 4.53
|
4.45 Units on a scale
Standard Deviation 4.33
|
4.81 Units on a scale
Standard Deviation 4.40
|
|
Total BDI-II (Beck Depression Inventory) Scores
Week 2, (n=43,44,43,47)
|
5.22 Units on a scale
Standard Deviation 5.27
|
4.84 Units on a scale
Standard Deviation 4.51
|
4.71 Units on a scale
Standard Deviation 5.16
|
5.60 Units on a scale
Standard Deviation 5.31
|
|
Total BDI-II (Beck Depression Inventory) Scores
Week 4, (n=42,45,44,45)
|
6.07 Units on a scale
Standard Deviation 4.77
|
6.31 Units on a scale
Standard Deviation 6.03
|
5.79 Units on a scale
Standard Deviation 5.50
|
7.21 Units on a scale
Standard Deviation 7.51
|
|
Total BDI-II (Beck Depression Inventory) Scores
Week 6, (n=41,41,43,44)
|
6.64 Units on a scale
Standard Deviation 5.71
|
6.32 Units on a scale
Standard Deviation 6.33
|
6.49 Units on a scale
Standard Deviation 5.40
|
8.19 Units on a scale
Standard Deviation 7.42
|
|
Total BDI-II (Beck Depression Inventory) Scores
Week 8, (n=38,42,42,40)
|
7.69 Units on a scale
Standard Deviation 6.90
|
6.20 Units on a scale
Standard Deviation 6.06
|
6.24 Units on a scale
Standard Deviation 5.39
|
8.02 Units on a scale
Standard Deviation 7.16
|
|
Total BDI-II (Beck Depression Inventory) Scores
Week 12, (n=44,46,42,44)
|
8.09 Units on a scale
Standard Deviation 8.12
|
6.82 Units on a scale
Standard Deviation 6.93
|
7.09 Units on a scale
Standard Deviation 5.76
|
8.09 Units on a scale
Standard Deviation 7.19
|
|
Total BDI-II (Beck Depression Inventory) Scores
Week 18, (n=43,44,42,40)
|
8.13 Units on a scale
Standard Deviation 7.86
|
8.04 Units on a scale
Standard Deviation 7.46
|
8.31 Units on a scale
Standard Deviation 6.91
|
8.62 Units on a scale
Standard Deviation 6.96
|
|
Total BDI-II (Beck Depression Inventory) Scores
Week 24, (n=43,45,41,37)
|
8.05 Units on a scale
Standard Deviation 6.37
|
7.07 Units on a scale
Standard Deviation 7.17
|
7.43 Units on a scale
Standard Deviation 7.04
|
8.80 Units on a scale
Standard Deviation 7.79
|
|
Total BDI-II (Beck Depression Inventory) Scores
Week 30, (n=38,42,39,34)
|
7.74 Units on a scale
Standard Deviation 6.14
|
8.03 Units on a scale
Standard Deviation 7.98
|
7.89 Units on a scale
Standard Deviation 6.80
|
9.35 Units on a scale
Standard Deviation 8.07
|
|
Total BDI-II (Beck Depression Inventory) Scores
Week 36, (n=36,42,37,33)
|
9.45 Units on a scale
Standard Deviation 8.71
|
7.50 Units on a scale
Standard Deviation 7.13
|
8.63 Units on a scale
Standard Deviation 8.09
|
7.82 Units on a scale
Standard Deviation 7.48
|
|
Total BDI-II (Beck Depression Inventory) Scores
Week 42, (n=35,37,35,32)
|
8.13 Units on a scale
Standard Deviation 5.43
|
7.49 Units on a scale
Standard Deviation 7.22
|
8.33 Units on a scale
Standard Deviation 8.06
|
8.00 Units on a scale
Standard Deviation 5.50
|
|
Total BDI-II (Beck Depression Inventory) Scores
Week 48, (n=34,40,31,29)
|
7.93 Units on a scale
Standard Deviation 5.13
|
7.48 Units on a scale
Standard Deviation 7.79
|
7.89 Units on a scale
Standard Deviation 7.79
|
7.92 Units on a scale
Standard Deviation 5.00
|
|
Total BDI-II (Beck Depression Inventory) Scores
Week 52, (n=31,36,32,28)
|
4.21 Units on a scale
Standard Deviation 3.79
|
4.56 Units on a scale
Standard Deviation 6.87
|
6.62 Units on a scale
Standard Deviation 8.59
|
4.22 Units on a scale
Standard Deviation 4.47
|
|
Total BDI-II (Beck Depression Inventory) Scores
Week 60, (n=34,34,31,28)
|
3.12 Units on a scale
Standard Deviation 4.00
|
4.47 Units on a scale
Standard Deviation 6.18
|
5.18 Units on a scale
Standard Deviation 6.61
|
3.40 Units on a scale
Standard Deviation 4.08
|
|
Total BDI-II (Beck Depression Inventory) Scores
Week 72, (n=28,37,28,29)
|
2.80 Units on a scale
Standard Deviation 4.59
|
5.00 Units on a scale
Standard Deviation 7.69
|
5.14 Units on a scale
Standard Deviation 6.61
|
2.92 Units on a scale
Standard Deviation 4.48
|
Adverse Events
PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg
Serious events: 4 serious events
Other events: 46 other events
Deaths: 0 deaths
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg
Serious events: 6 serious events
Other events: 46 other events
Deaths: 0 deaths
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg
Serious events: 6 serious events
Other events: 47 other events
Deaths: 0 deaths
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
Serious events: 5 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg
n=46 participants at risk
Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered \[subcutaneously\] sc, once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered \[orally \] po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg
n=47 participants at risk
Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg
n=47 participants at risk
Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
n=47 participants at risk
Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
1/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Blood and lymphatic system disorders
Anaemia Haemolytic Autoimmune
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Psychiatric disorders
Depression
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Psychiatric disorders
Homicidal Ideation
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Psychiatric disorders
Psychotic disorder
|
2.2%
1/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Psychiatric disorders
Suicide attempt
|
2.2%
1/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
2.2%
1/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
2.2%
1/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non Hodgkin's Lymphoma
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Eye disorders
Retinal Vascular Disorder
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
General disorders
Pyrexia
|
2.2%
1/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Reproductive system and breast disorders
Haemorrhagic Ovarian Cyst
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
Other adverse events
| Measure |
PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg
n=46 participants at risk
Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered \[subcutaneously\] sc, once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered \[orally \] po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg
n=47 participants at risk
Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg
n=47 participants at risk
Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
|
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
n=47 participants at risk
Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.5%
3/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
12.8%
6/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
25.5%
12/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Ear and labyrinth disorders
Vertigio
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Eye disorders
Vision blurred
|
10.9%
5/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
10.6%
5/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.7%
4/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
12.8%
6/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Gastrointestinal disorders
Constipation
|
6.5%
3/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.1%
12/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
19.1%
9/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
23.4%
11/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
21.3%
10/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Gastrointestinal disorders
Dry Mouth
|
4.3%
2/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
12.8%
6/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
3/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
10.6%
5/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Gastrointestinal disorders
Nausea
|
39.1%
18/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
42.6%
20/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
38.3%
18/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
38.3%
18/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Gastrointestinal disorders
Stomatitis
|
2.2%
1/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Gastrointestinal disorders
Toothache
|
8.7%
4/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Gastrointestinal disorders
Vomiting
|
13.0%
6/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
10.6%
5/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
14.9%
7/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
10.6%
5/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
General disorders
Asthenia
|
6.5%
3/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
10.6%
5/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
General disorders
Chest discomfort
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
General disorders
Chills
|
32.6%
15/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
29.8%
14/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
40.4%
19/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
36.2%
17/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
General disorders
Fatigue
|
78.3%
36/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
68.1%
32/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
74.5%
35/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
72.3%
34/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
General disorders
Injection site erythema
|
21.7%
10/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
19.1%
9/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
12.8%
6/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
10.6%
5/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
General disorders
Injection site rash
|
4.3%
2/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
General disorders
Injection site reaction
|
8.7%
4/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
General disorders
Irritability
|
30.4%
14/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
29.8%
14/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
25.5%
12/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
34.0%
16/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
General disorders
Malaise
|
2.2%
1/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
10.6%
5/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
General disorders
Pain
|
8.7%
4/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
General disorders
Pyrexia
|
26.1%
12/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
29.8%
14/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
34.0%
16/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
29.8%
14/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Infections and infestations
Cellulitis
|
4.3%
2/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Infections and infestations
Herpes Simplex
|
6.5%
3/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Infections and infestations
Oral Candidiasis
|
2.2%
1/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Infections and infestations
Sinusitis
|
6.5%
3/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Infections and infestations
Upper Respiratory tract infection
|
4.3%
2/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
10.6%
5/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
12.8%
6/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.5%
3/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Investigations
Weight Decreased
|
13.0%
6/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
10.6%
5/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
14.9%
7/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Metabolism and nutrition disorders
Anorexia
|
13.0%
6/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
12.8%
6/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
10.9%
5/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
10.6%
5/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
19.1%
9/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
17.0%
8/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
4.3%
2/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
10.6%
5/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.3%
13/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
34.0%
16/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
34.0%
16/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
31.9%
15/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
23.4%
11/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
4.3%
2/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
10.6%
5/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.4%
14/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
31.9%
15/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
40.4%
19/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
34.0%
16/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Nervous system disorders
Disturbance in attention
|
19.6%
9/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
14.9%
7/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
12.8%
6/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Nervous system disorders
Dizziness
|
26.1%
12/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
19.1%
9/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
14.9%
7/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
19.1%
9/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Nervous system disorders
Dysgeusia
|
6.5%
3/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
17.0%
8/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Nervous system disorders
Headache
|
52.2%
24/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
38.3%
18/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
46.8%
22/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
44.7%
21/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Nervous system disorders
Memory impairment
|
17.4%
8/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
10.6%
5/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Nervous system disorders
Tremor
|
2.2%
1/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Psychiatric disorders
Anger
|
6.5%
3/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Psychiatric disorders
Anxiety
|
15.2%
7/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
14.9%
7/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
17.0%
8/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Psychiatric disorders
Depression
|
30.4%
14/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
42.6%
20/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
23.4%
11/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
34.0%
16/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Psychiatric disorders
Insomnia
|
39.1%
18/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
42.6%
20/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
46.8%
22/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
51.1%
24/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Psychiatric disorders
Sleep disorder
|
6.5%
3/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.6%
9/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
25.5%
12/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
25.5%
12/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
17.0%
8/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.6%
9/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
25.5%
12/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
17.0%
8/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
25.5%
12/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
13.0%
6/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
10.6%
5/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
1/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.5%
3/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
2.2%
1/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract conjestion
|
2.2%
1/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.7%
4/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
10.6%
5/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
10.6%
5/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
12.8%
6/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
6.5%
3/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
10.6%
5/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.9%
5/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
17.0%
8/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
4.3%
2/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.2%
7/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
12.8%
6/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
6.4%
3/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.1%
12/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
23.4%
11/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
31.9%
15/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
25.5%
12/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Skin and subcutaneous tissue disorders
Rash Generalised
|
4.3%
2/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
4.3%
2/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
|
Vascular disorders
Hypertension
|
0.00%
0/46 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
0.00%
0/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
2.1%
1/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
8.5%
4/47 • Up to Week 72
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 616878333
Email: [email protected]
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