Trial Outcomes & Findings for A Study of the Safety and Efficacy of Pegylated Inferferon Alfa-2b (PEG-Intron™) Versus Pegylated Interferon Alfa-2a (PEGASYS™) in Participants With Chronic Hepatitis B (P08450) (NCT NCT01641926)
NCT ID: NCT01641926
Last Updated: 2018-08-27
Results Overview
Blood samples were drawn to assess the participant's seroconversion status at Follow-up (FU) Week 24. HBeAg seroconversion was defined as loss of HBeAg in HBeAg(+) participants and development of antibody to HBeAg.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
402 participants
Primary outcome timeframe
FU Week 24 (Study Week 72)
Results posted on
2018-08-27
Participant Flow
Hepatitis B envelope antigen (HBeAg)-positive or -negative participants who were interferon treatment-naïve were recruited from 81 sites to be randomly assigned to receive pegylated inferferon alfa-2b (PEG-Intron™) or pegylated interferon alfa-2a (PEGASYS™).
402 participants were enrolled and 399 participants were treated on study.
Participant milestones
| Measure |
HBeAg(+) PEG-Intron
HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
|
HBeAg(+) PEGASYS
HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
HBeAg(-) PEG-Intron
HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
|
HBeAg(-) PEGASYS
HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
143
|
145
|
57
|
57
|
|
Overall Study
Treated (All Participants as Treated)
|
142
|
144
|
56
|
57
|
|
Overall Study
COMPLETED
|
115
|
130
|
46
|
53
|
|
Overall Study
NOT COMPLETED
|
28
|
15
|
11
|
4
|
Reasons for withdrawal
| Measure |
HBeAg(+) PEG-Intron
HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
|
HBeAg(+) PEGASYS
HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
HBeAg(-) PEG-Intron
HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
|
HBeAg(-) PEGASYS
HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
2
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
1
|
0
|
|
Overall Study
Physician Decision
|
6
|
5
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
13
|
5
|
6
|
1
|
|
Overall Study
Not Treated
|
1
|
1
|
1
|
0
|
Baseline Characteristics
A Study of the Safety and Efficacy of Pegylated Inferferon Alfa-2b (PEG-Intron™) Versus Pegylated Interferon Alfa-2a (PEGASYS™) in Participants With Chronic Hepatitis B (P08450)
Baseline characteristics by cohort
| Measure |
HBeAg(+) PEG-Intron
n=142 Participants
HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
|
HBeAg(+) PEGASYS
n=144 Participants
HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
HBeAg(-) PEG-Intron
n=56 Participants
HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
|
HBeAg(-) PEGASYS
n=57 Participants
HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 7.73 • n=5 Participants
|
33.6 years
STANDARD_DEVIATION 9.23 • n=7 Participants
|
41.1 years
STANDARD_DEVIATION 10.77 • n=5 Participants
|
42.0 years
STANDARD_DEVIATION 10.50 • n=4 Participants
|
35.5 years
STANDARD_DEVIATION 9.91 • n=21 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
133 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
266 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
142 participants
n=5 Participants
|
144 participants
n=7 Participants
|
56 participants
n=5 Participants
|
57 participants
n=4 Participants
|
399 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: FU Week 24 (Study Week 72)Population: All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not analyzed for HBeAg seroconversion.
Blood samples were drawn to assess the participant's seroconversion status at Follow-up (FU) Week 24. HBeAg seroconversion was defined as loss of HBeAg in HBeAg(+) participants and development of antibody to HBeAg.
Outcome measures
| Measure |
HBeAg(+) PEG-Intron
n=142 Participants
HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
|
HBeAg(+) PEGASYS
n=144 Participants
HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
HBeAg(-) PEG-Intron
HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
|
HBeAg(-) PEGASYS
HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of HBeAg(+) Participants Achieving HBeAg Seroconversion at 24 Weeks Post-treatment
|
25.4 percentage of participants
|
23.6 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: FU Week 24 (Study Week 72)Population: All randomized HBeAg(-) participants who received ≥1 dose of study medication. HBeAg(+) participants were not included in this analysis.
The Roche COBAS TaqMan HBV-(High Pure System Assay) was used to measure HBV DNA in blood samples of HBeAg(-) participants. The percentage of HBeAg(-) participants with HBV DNA \<2000 IU/mL at 24 weeks post-treatment was reported.
Outcome measures
| Measure |
HBeAg(+) PEG-Intron
HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
|
HBeAg(+) PEGASYS
HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
HBeAg(-) PEG-Intron
n=56 Participants
HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
|
HBeAg(-) PEGASYS
n=57 Participants
HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of HBeAg(-) Participants Achieving Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels <2000 IU/mL at 24 Weeks Post-treatment
|
—
|
—
|
30.4 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: FU Week 24 (Study Week 72)Population: All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not included in this analysis.
The Roche COBAS TaqMan HBV-(High Pure System Assay) was used to measure HBV DNA in blood samples of HBeAg(+)participants. The percentage of HBeAg(+) participants with HBV DNA \<2000 IU/mL at 24 weeks post-treatment was reported.
Outcome measures
| Measure |
HBeAg(+) PEG-Intron
n=142 Participants
HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
|
HBeAg(+) PEGASYS
n=144 Participants
HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
HBeAg(-) PEG-Intron
HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
|
HBeAg(-) PEGASYS
HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of HBeAg(+) Participants Achieving HBV DNA <2000 IU/mL at 24 Weeks Post-treatment
|
23.9 percentage of participants
|
21.5 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: FU Week 24 (Study Week 72)Population: All randomized HBeAg(+) and HBeAg(-) participants who received ≥1 dose of study medication.
ALT normalization is a desired goal of HBV treatment, which is defined as having abnormal ALT levels at baseline and subsequently normal ALT levels after receiving treatment, where normal is defined as ≤ 1x the upper limit of normal (ULN). The percentage of HBeAg(+) and HBeAg(-) participants achieving ALT normalization at 24 weeks post-treatment was reported.
Outcome measures
| Measure |
HBeAg(+) PEG-Intron
n=142 Participants
HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
|
HBeAg(+) PEGASYS
n=144 Participants
HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
HBeAg(-) PEG-Intron
n=56 Participants
HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
|
HBeAg(-) PEGASYS
n=57 Participants
HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of HBeAg(+) and HBeAg(-) Participants Achieving Alanine Aminotransferase (ALT) Normalization at 24 Weeks Post-treatment
|
49.3 percentage of participants
|
47.2 percentage of participants
|
71.4 percentage of participants
|
61.4 percentage of participants
|
SECONDARY outcome
Timeframe: FU Week 24 (Study Week 72)Population: All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not included in this analysis.
HBeAg seroconversion was defined as loss of HBeAg in HBeAg(+) participants and development of antibody to HBeAg. HBV DNA levels in blood were measured by the Roche COBAS TaqMan HBV-(High Pure System Assay). The percentage of HBeAg(+) participants with the combined response of achieving both HBeAg conversion and HBV DNA levels \<2000 IU/mL at 24 weeks post-treatment was reported.
Outcome measures
| Measure |
HBeAg(+) PEG-Intron
n=142 Participants
HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
|
HBeAg(+) PEGASYS
n=144 Participants
HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
HBeAg(-) PEG-Intron
HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
|
HBeAg(-) PEGASYS
HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of HBeAg(+) Participants Achieving the Combined Response of HBeAg Seroconversion and HBV DNA <2000 IU/mL at 24 Weeks Post-treatment
|
14.8 percentage of participants
|
13.9 percentage of participants
|
—
|
—
|
Adverse Events
HBeAg(+) PEG-Intron
Serious events: 12 serious events
Other events: 126 other events
Deaths: 0 deaths
HBeAg(+) PEGASYS
Serious events: 10 serious events
Other events: 124 other events
Deaths: 0 deaths
HBeAg(-) PEG-Intron
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
HBeAG(-) PEGASYS
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HBeAg(+) PEG-Intron
n=142 participants at risk
HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
|
HBeAg(+) PEGASYS
n=144 participants at risk
HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
HBeAg(-) PEG-Intron
n=56 participants at risk
HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
|
HBeAG(-) PEGASYS
n=57 participants at risk
HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/142 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.69%
1/144 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/142 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.69%
1/144 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Endocrine disorders
Basedow's disease
|
0.70%
1/142 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/144 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/142 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.69%
1/144 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Eye disorders
Retinal vein occlusion
|
0.70%
1/142 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/144 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/142 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.69%
1/144 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.70%
1/142 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/144 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/142 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.4%
2/144 • Number of events 2 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/142 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.69%
1/144 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/142 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.69%
1/144 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
General disorders
Asthenia
|
0.70%
1/142 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/144 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
General disorders
Pyrexia
|
0.70%
1/142 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/144 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.70%
1/142 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.69%
1/144 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/142 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/144 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.8%
1/57 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatitis
|
0.70%
1/142 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.69%
1/144 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.8%
1/57 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.70%
1/142 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/144 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Infections and infestations
Diverticulitis
|
0.70%
1/142 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/144 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/142 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.69%
1/144 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.70%
1/142 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/144 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.70%
1/142 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/144 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/142 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.69%
1/144 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/142 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.4%
2/144 • Number of events 3 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Investigations
Weight decreased
|
0.00%
0/142 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.69%
1/144 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/142 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.69%
1/144 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/142 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.69%
1/144 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Psychiatric disorders
Depression
|
0.70%
1/142 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/144 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/142 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/144 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.8%
1/56 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
Other adverse events
| Measure |
HBeAg(+) PEG-Intron
n=142 participants at risk
HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
|
HBeAg(+) PEGASYS
n=144 participants at risk
HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
HBeAg(-) PEG-Intron
n=56 participants at risk
HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
|
HBeAG(-) PEGASYS
n=57 participants at risk
HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
8.5%
12/142 • Number of events 18 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
9.0%
13/144 • Number of events 17 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
8.9%
5/56 • Number of events 9 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
3.5%
2/57 • Number of events 3 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Eye disorders
Vision blurred
|
1.4%
2/142 • Number of events 2 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
2.1%
3/144 • Number of events 3 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
5.3%
3/57 • Number of events 4 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
11/142 • Number of events 19 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
5.6%
8/144 • Number of events 19 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
7.1%
4/56 • Number of events 6 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
5.3%
3/57 • Number of events 3 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
0.70%
1/142 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.69%
1/144 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
7.1%
4/56 • Number of events 4 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
3.5%
2/57 • Number of events 2 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.5%
5/142 • Number of events 5 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
8.3%
12/144 • Number of events 15 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.8%
1/56 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.8%
1/57 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/142 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
2.1%
3/144 • Number of events 3 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
7.1%
4/56 • Number of events 4 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.8%
1/57 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Gastrointestinal disorders
Mouth ulceration
|
3.5%
5/142 • Number of events 7 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
2.8%
4/144 • Number of events 5 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
3.6%
2/56 • Number of events 2 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
5.3%
3/57 • Number of events 3 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
3.5%
5/142 • Number of events 6 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
6.2%
9/144 • Number of events 15 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.8%
1/56 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
5.3%
3/57 • Number of events 3 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
General disorders
Asthenia
|
5.6%
8/142 • Number of events 8 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
2.1%
3/144 • Number of events 3 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
3.6%
2/56 • Number of events 2 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
General disorders
Chest discomfort
|
1.4%
2/142 • Number of events 2 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.69%
1/144 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.8%
1/56 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
7.0%
4/57 • Number of events 4 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
General disorders
Fatigue
|
26.1%
37/142 • Number of events 38 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
20.8%
30/144 • Number of events 35 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
17.9%
10/56 • Number of events 11 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
15.8%
9/57 • Number of events 12 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
General disorders
Influenza like illness
|
12.0%
17/142 • Number of events 84 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
13.2%
19/144 • Number of events 24 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
10.7%
6/56 • Number of events 8 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
19.3%
11/57 • Number of events 13 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
General disorders
Injection site erythema
|
7.7%
11/142 • Number of events 11 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
2.1%
3/144 • Number of events 4 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
5.4%
3/56 • Number of events 3 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
3.5%
2/57 • Number of events 2 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
General disorders
Injection site reaction
|
6.3%
9/142 • Number of events 9 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.4%
2/144 • Number of events 2 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
10.7%
6/56 • Number of events 6 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
General disorders
Malaise
|
1.4%
2/142 • Number of events 2 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.4%
2/144 • Number of events 3 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.8%
1/56 • Number of events 2 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
8.8%
5/57 • Number of events 10 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
General disorders
Pain
|
6.3%
9/142 • Number of events 9 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
2.8%
4/144 • Number of events 4 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.8%
1/57 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
General disorders
Pyrexia
|
46.5%
66/142 • Number of events 116 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
38.2%
55/144 • Number of events 97 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
37.5%
21/56 • Number of events 86 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
35.1%
20/57 • Number of events 35 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
6/142 • Number of events 6 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
6.9%
10/144 • Number of events 12 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
5.4%
3/56 • Number of events 3 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
3.5%
2/57 • Number of events 4 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Infections and infestations
Rhinitis
|
0.70%
1/142 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/144 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
5.3%
3/57 • Number of events 3 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
2/142 • Number of events 2 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
3.5%
5/144 • Number of events 5 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
7.1%
4/56 • Number of events 4 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
7.0%
4/57 • Number of events 4 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
4.2%
6/142 • Number of events 6 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
8.3%
12/144 • Number of events 12 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.8%
1/56 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
8.8%
5/57 • Number of events 5 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
2.8%
4/142 • Number of events 4 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
4.2%
6/144 • Number of events 7 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
5.4%
3/56 • Number of events 3 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
5.3%
3/57 • Number of events 3 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Investigations
Neutrophil count decreased
|
4.2%
6/142 • Number of events 16 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
3.5%
5/144 • Number of events 10 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
3.6%
2/56 • Number of events 4 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
7.0%
4/57 • Number of events 11 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Investigations
Platelet count decreased
|
0.70%
1/142 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
2.1%
3/144 • Number of events 4 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
7.0%
4/57 • Number of events 6 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Investigations
Weight decreased
|
6.3%
9/142 • Number of events 10 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
11.1%
16/144 • Number of events 16 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
16.1%
9/56 • Number of events 9 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
7.0%
4/57 • Number of events 4 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.0%
17/142 • Number of events 19 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
14.6%
21/144 • Number of events 23 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
8.9%
5/56 • Number of events 6 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
10.5%
6/57 • Number of events 6 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
11/142 • Number of events 20 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
4.9%
7/144 • Number of events 18 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
5.4%
3/56 • Number of events 3 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
5.3%
3/57 • Number of events 3 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.5%
5/142 • Number of events 5 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
2.8%
4/144 • Number of events 6 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
5.4%
3/56 • Number of events 6 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
7.0%
4/57 • Number of events 5 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.3%
43/142 • Number of events 60 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
24.3%
35/144 • Number of events 56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
37.5%
21/56 • Number of events 29 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
22.8%
13/57 • Number of events 27 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
2/142 • Number of events 2 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
2.1%
3/144 • Number of events 5 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
5.4%
3/56 • Number of events 3 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.8%
1/57 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
9.9%
14/142 • Number of events 15 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
9.0%
13/144 • Number of events 24 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
10.7%
6/56 • Number of events 8 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
8.8%
5/57 • Number of events 10 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Nervous system disorders
Headache
|
33.8%
48/142 • Number of events 100 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
24.3%
35/144 • Number of events 94 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
28.6%
16/56 • Number of events 32 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
24.6%
14/57 • Number of events 31 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Psychiatric disorders
Depression
|
5.6%
8/142 • Number of events 8 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.4%
2/144 • Number of events 2 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
0.00%
0/56 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.8%
1/57 • Number of events 2 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
8.5%
12/142 • Number of events 14 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
6.9%
10/144 • Number of events 16 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
8.9%
5/56 • Number of events 6 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
10.5%
6/57 • Number of events 6 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.9%
7/142 • Number of events 11 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
3.5%
5/144 • Number of events 5 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
10.7%
6/56 • Number of events 7 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
7.0%
4/57 • Number of events 4 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
4/142 • Number of events 5 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
6.9%
10/144 • Number of events 10 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.8%
1/56 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
5.3%
3/57 • Number of events 6 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.1%
57/142 • Number of events 57 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
37.5%
54/144 • Number of events 54 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
32.1%
18/56 • Number of events 18 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
24.6%
14/57 • Number of events 14 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.3%
9/142 • Number of events 13 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
9.7%
14/144 • Number of events 14 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
12.5%
7/56 • Number of events 8 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
10.5%
6/57 • Number of events 7 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
6/142 • Number of events 7 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
8.3%
12/144 • Number of events 12 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
1.8%
1/56 • Number of events 1 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
3.5%
2/57 • Number of events 2 • SAEs up to 30 days after Week 24 Post-Treatment Visit (up to 76 weeks) Nonserious AEs up to Treatment Week 48 (up to 48 weeks)
APaT population; all randomized participants who received ≥1 dose of study medication.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts.
- Publication restrictions are in place
Restriction type: OTHER