Trial Outcomes & Findings for Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB) (NCT NCT04676724)
NCT ID: NCT04676724
Last Updated: 2024-05-02
Results Overview
Sustained virologic response is defined as undetectable levels of Hepatitis B surface antigen (HBsAg) and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as HBsAg and HBV DNA levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of sequential treatment of GSK3228836 and PegIFN treatment which is sustained for 24 weeks post-GSK3228836 and PegIFN treatment in the absence of any rescue medication. Percentage values are rounded-off.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
Up to 24 weeks off treatment (Study Weeks 48 to 72)
Results posted on
2024-05-02
Participant Flow
A total of 108 participants were enrolled in this study.
Participants who were on stable nucleos(t)ide analogue (NA) therapy randomized (1:1) into one of 2 parallel treatment arms. Treatment arm 1: 300 mg/week GSK3228836 for 24 weeks + PegIFN 180 mcg/week for 24 weeks; on-treatment until Week 48 and off-treatment from Weeks 48 to 72. Treatment arm 2: 300 mg/week GSK3228836 for 12 weeks + 180 mcg/week PegIFN for 24 weeks, on-treatment until Week 36 and off-treatment follow-up from Weeks 36 to Week 60 and 72.
Participant milestones
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300 milligrams per week (mg/week) GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by Pegylated Interferon (PegIFN) 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
53
|
|
Overall Study
COMPLETED
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300 milligrams per week (mg/week) GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by Pegylated Interferon (PegIFN) 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB)
Baseline characteristics by cohort
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=55 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
n=53 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.5 YEARS
STANDARD_DEVIATION 10.73 • n=5 Participants
|
45.5 YEARS
STANDARD_DEVIATION 9.35 • n=7 Participants
|
45.5 YEARS
STANDARD_DEVIATION 10.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
30 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeks off treatment (Study Weeks 48 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants.
Sustained virologic response is defined as undetectable levels of Hepatitis B surface antigen (HBsAg) and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as HBsAg and HBV DNA levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of sequential treatment of GSK3228836 and PegIFN treatment which is sustained for 24 weeks post-GSK3228836 and PegIFN treatment in the absence of any rescue medication. Percentage values are rounded-off.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=55 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 1 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment
|
9 Percentage of Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 24 weeks off treatment (Study Weeks 36 to 60)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Sustained virologic response is defined as undetectable levels of Hepatitis B surface antigen (HBsAg) and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as HBsAg and HBV DNA levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of sequential treatment of GSK3228836 and PegIFN treatment which is sustained for 24 weeks post-GSK3228836 and PegIFN treatment in the absence of any rescue medication. Percentage values are rounded-off.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=53 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 2 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment
|
15 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Percentage of participants achieving HBsAg and HBV DNA \<LLOQ were reported. Percentage values are rounded-off.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=49 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 1: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ)
End of treatment (up to 48 weeks)
|
15 Percentage of Participants
|
—
|
|
Treatment Arm 1: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ)
Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
13 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Percentage of participants achieving HBsAg and HBV DNA \<LLOQ were reported. Percentage values are rounded-off.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=50 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ)
End of treatment (up to 36 weeks)
|
15 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ)
Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
17 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ)
Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
15 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, End of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Participants who achieved a decline in HBsAg values from baseline were reported. Participants were categorized in the following categorical HBsAg decline of \<0.5, greater than or equal to (\>=) 0.5, \>=1, \>=1.5, and \>=3 log10 international units per milliliter (IU/mL). The 'HBsAg \< LLOQ' category is derived based on Absolute/raw HBsAg result. The HBsAg decline categories are based on change from baseline values. Percentage values are rounded-off.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=49 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg <LLOQ - End of Treatment (up to 48 weeks)
|
18 Percentage of Participants
|
—
|
|
Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg<LLOQ - Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
13 Percentage of Participants
|
—
|
|
Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline <0.5 - End of Treatment (up to 48 weeks)
|
24 Percentage of Participants
|
—
|
|
Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline <0.5- Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
45 Percentage of Participants
|
—
|
|
Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=0.5 - End of Treatment (up to 48 weeks)
|
42 Percentage of Participants
|
—
|
|
Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=0.5 - Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
44 Percentage of Participants
|
—
|
|
Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=1 - End of Treatment (up to 48 weeks)
|
33 Percentage of Participants
|
—
|
|
Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=1- Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
36 Percentage of Participants
|
—
|
|
Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=1.5 - End of Treatment (up to 48 weeks)
|
27 Percentage of Participants
|
—
|
|
Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=1.5 - Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
36 Percentage of Participants
|
—
|
|
Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=3 - End of Treatment (up to 48 weeks)
|
20 Percentage of Participants
|
—
|
|
Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=3 - Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
27 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Participants who achieved a decline in HBsAg values from baseline were reported. Participants were categorized in the following categorical HBsAg decline of \<0.5, greater than or equal to (\>=) 0.5, \>=1, \>=1.5, and \>=3 log10 international units per milliliter (IU/mL). The 'HBsAg \< LLOQ' category is derived based on Absolute/raw HBsAg result. The HBsAg decline categories are based on change from baseline values. Percentage values are rounded-off.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=50 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=1 - Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
34 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=1 - Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
32 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=3 - End of Treatment (up to 36 weeks)
|
15 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg <LLOQ - End of Treatment (up to 36 weeks)
|
15 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg<LLOQ - Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
17 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg <LLOQ - Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
15 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline <0.5 - End of Treatment (up to 36 weeks)
|
26 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline <0.5 - Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
42 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline <0.5 - Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
43 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=0.5 - End of Treatment (up to 36 weeks)
|
42 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=0.5 - Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
51 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=0.5 - Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
47 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=1 - End of Treatment (up to 36 weeks)
|
34 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=1.5 - End of Treatment (up to 36 weeks)
|
28 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=1.5 - Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
23 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=1.5-up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
19 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=3 - Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
17 Percentage of Participants
|
—
|
|
Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values
HBsAg decline >=3 - Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
17 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. The "n" represents the number of participants with baseline ALT \> ULN and ALT data at that visit. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
The ALT normalization (ALT \<=upper limit of normal \[ULN\]) over time in absence of rescue medication in participants with baseline ALT\>ULN and ALT data at that visit. Participants who achieved ALT normalization were reported.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=55 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 1: Number of Participants With Alanine Aminotransferase (ALT) Normalization
ALT>ULN, At Baseline
|
4 Participants
|
—
|
|
Treatment Arm 1: Number of Participants With Alanine Aminotransferase (ALT) Normalization
ALT normalization, End of Treatment (up to 48 weeks)
|
0 Participants
|
—
|
|
Treatment Arm 1: Number of Participants With Alanine Aminotransferase (ALT) Normalization
ALT normalization, Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. The "n" represents the number of participants with baseline ALT \> ULN and ALT data at that visit. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
The ALT normalization (ALT \<=upper limit of normal \[ULN\]) over time in absence of rescue medication in participants with baseline ALT\>ULN and ALT data at that visit. Participants who achieved ALT normalization were reported.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=53 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 2: Number of Participants With Alanine Aminotransferase (ALT) Normalization
ALT>ULN, At Baseline
|
10 Participants
|
—
|
|
Treatment Arm 2: Number of Participants With Alanine Aminotransferase (ALT) Normalization
ALT normalization, End of Treatment (up to 36 weeks)
|
1 Participants
|
—
|
|
Treatment Arm 2: Number of Participants With Alanine Aminotransferase (ALT) Normalization
ALT normalization, Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
5 Participants
|
—
|
|
Treatment Arm 2: Number of Participants With Alanine Aminotransferase (ALT) Normalization
ALT normalization, Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=13 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 1: Number of Participants With HBe Antibody (Anti-HBeAg) Levels
At Baseline
|
2 Participants
|
—
|
|
Treatment Arm 1: Number of Participants With HBe Antibody (Anti-HBeAg) Levels
End of Treatment (up to 48 weeks)
|
5 Participants
|
—
|
|
Treatment Arm 1: Number of Participants With HBe Antibody (Anti-HBeAg) Levels
Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=14 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 2: Number of Participants With HBe Antibody (Anti-HBeAg) Levels
At Baseline
|
1 Participants
|
—
|
|
Treatment Arm 2: Number of Participants With HBe Antibody (Anti-HBeAg) Levels
End of Treatment (up to 36 weeks)
|
1 Participants
|
—
|
|
Treatment Arm 2: Number of Participants With HBe Antibody (Anti-HBeAg) Levels
Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
1 Participants
|
—
|
|
Treatment Arm 2: Number of Participants With HBe Antibody (Anti-HBeAg) Levels
Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=14 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 1: Mean Change From Baseline in HBe Antibody Levels
End of Treatment (up to 48 weeks)
|
-1.04 Log10 IU/mL
Standard Deviation 1.133
|
—
|
|
Treatment Arm 1: Mean Change From Baseline in HBe Antibody Levels
Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
-0.81 Log10 IU/mL
Standard Deviation 1.044
|
—
|
SECONDARY outcome
Timeframe: At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=13 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 2: Mean Change From Baseline in HBe Antibody Levels
End of Treatment (up to 36 weeks)
|
-0.52 Log10 IU/mL
Standard Deviation 0.598
|
—
|
|
Treatment Arm 2: Mean Change From Baseline in HBe Antibody Levels
Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
-0.58 Log10 IU/mL
Standard Deviation 0.766
|
—
|
|
Treatment Arm 2: Mean Change From Baseline in HBe Antibody Levels
Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
-0.65 Log10 IU/mL
Standard Deviation 0.787
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected from participants to assess HBsAg at indicated time points.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=55 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 1: Actual Values of HBsAg Levels
At Baseline
|
3.34 Log10 IU/mL
Standard Deviation 0.555
|
—
|
|
Treatment Arm 1: Actual Values of HBsAg Levels
End of Treatment (up to 48 weeks)
|
1.52 Log10 IU/mL
Standard Deviation 2.071
|
—
|
|
Treatment Arm 1: Actual Values of HBsAg Levels
Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
1.72 Log10 IU/mL
Standard Deviation 2.043
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected from participants to assess HBsAg at indicated time points.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=53 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 2: Actual Values of HBsAg Levels
At Baseline
|
3.32 Log10 IU/mL
Standard Deviation 0.622
|
—
|
|
Treatment Arm 2: Actual Values of HBsAg Levels
End of Treatment (up to 36 weeks)
|
1.70 Log10 IU/mL
Standard Deviation 1.896
|
—
|
|
Treatment Arm 2: Actual Values of HBsAg Levels
Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
2.12 Log10 IU/mL
Standard Deviation 1.827
|
—
|
|
Treatment Arm 2: Actual Values of HBsAg Levels
Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
2.12 Log10 IU/mL
Standard Deviation 1.830
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBsAg change from baselines levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=49 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 1: Mean Change From Baseline in HBsAg Levels
Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
-1.58 Log10 IU/mL
Standard Deviation 1.722
|
—
|
|
Treatment Arm 1: Mean Change From Baseline in HBsAg Levels
End of Treatment (up to 48 weeks)
|
-1.76 Log10 IU/mL
Standard Deviation 1.726
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBsAg change from baselines levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=49 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 2: Mean Change From Baseline in HBsAg Levels
End of Treatment (up to 36 weeks)
|
-1.54 Log10 IU/mL
Standard Deviation 1.567
|
—
|
|
Treatment Arm 2: Mean Change From Baseline in HBsAg Levels
Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
-1.20 Log10 IU/mL
Standard Deviation 1.458
|
—
|
|
Treatment Arm 2: Mean Change From Baseline in HBsAg Levels
Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
-1.20 Log10 IU/mL
Standard Deviation 1.460
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBV DNA levels.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=55 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 1: Actual Values of HBV DNA Levels
At Baseline
|
0.64 Log10 IU/mL
Standard Deviation 0.796
|
—
|
|
Treatment Arm 1: Actual Values of HBV DNA Levels
End of Treatment (up to 48 weeks)
|
0.97 Log10 IU/mL
Standard Deviation 0.629
|
—
|
|
Treatment Arm 1: Actual Values of HBV DNA Levels
Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
0.17 Log10 IU/mL
Standard Deviation 0.438
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBV DNA levels.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=53 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 2: Actual Values of HBV DNA Levels
At Baseline
|
0.57 Log10 IU/mL
Standard Deviation 0.687
|
—
|
|
Treatment Arm 2: Actual Values of HBV DNA Levels
End of treatment (up to 36 weeks)
|
0.70 Log10 IU/mL
Standard Deviation 0.700
|
—
|
|
Treatment Arm 2: Actual Values of HBV DNA Levels
Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
0.34 Log10 IU/mL
Standard Deviation 0.579
|
—
|
|
Treatment Arm 2: Actual Values of HBV DNA Levels
Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
0.35 Log10 IU/mL
Standard Deviation 0.587
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBV DNA levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=47 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 1: Mean Change From Baseline in HBV DNA Levels
End of treatment (up to 48 weeks)
|
0.40 Log10 IU/mL
Standard Deviation 0.945
|
—
|
|
Treatment Arm 1: Mean Change From Baseline in HBV DNA Levels
Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
-0.39 Log10 IU/mL
Standard Deviation 0.727
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBV DNA levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=49 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 2: Mean Change From Baseline in HBV DNA Levels
End of Treatment (up to 36 weeks)
|
0.21 Log10 IU/mL
Standard Deviation 0.925
|
—
|
|
Treatment Arm 2: Mean Change From Baseline in HBV DNA Levels
Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
-0.21 Log10 IU/mL
Standard Deviation 0.876
|
—
|
|
Treatment Arm 2: Mean Change From Baseline in HBV DNA Levels
Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
-0.22 Log10 IU/mL
Standard Deviation 0.754
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBeAg levels.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=55 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 1: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels
At Baseline
|
14.221 Log10 IU/mL
Standard Deviation 69.3438
|
—
|
|
Treatment Arm 1: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels
End of Treatment (up to 48 weeks)
|
0.250 Log10 IU/mL
Standard Deviation 0.4193
|
—
|
|
Treatment Arm 1: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels
Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
1.197 Log10 IU/mL
Standard Deviation 2.4945
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBeAg levels.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=53 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 2: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels
End of Treatment (up to 36 weeks)
|
3.008 Log10 IU/mL
Standard Deviation 6.2682
|
—
|
|
Treatment Arm 2: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels
Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
3.410 Log10 IU/mL
Standard Deviation 6.0421
|
—
|
|
Treatment Arm 2: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels
Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
2.797 Log10 IU/mL
Standard Deviation 4.8973
|
—
|
|
Treatment Arm 2: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels
At Baseline
|
8.510 Log10 IU/mL
Standard Deviation 42.1588
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBeAg levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=15 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 1: Mean Change From Baseline in HBeAg Levels
End of Treatment (up to 48 weeks)
|
-21.774 Log10 IU/mL
Standard Deviation 65.4276
|
—
|
|
Treatment Arm 1: Mean Change From Baseline in HBeAg Levels
Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
-19.482 Log10 IU/mL
Standard Deviation 55.1948
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBeAg levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=15 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 2: Mean Change From Baseline in HBeAg Levels
End of Treatment (up to 36 weeks)
|
-5.270 Log10 IU/mL
Standard Deviation 8.8942
|
—
|
|
Treatment Arm 2: Mean Change From Baseline in HBeAg Levels
Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
-26.384 Log10 IU/mL
Standard Deviation 80.2108
|
—
|
|
Treatment Arm 2: Mean Change From Baseline in HBeAg Levels
Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
-26.345 Log10 IU/mL
Standard Deviation 77.2836
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBs antibody levels.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=54 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 1: Actual Values of HBs Antibody Levels
At Baseline
|
0.62 Log10 IU/L
Standard Deviation 0.271
|
—
|
|
Treatment Arm 1: Actual Values of HBs Antibody Levels
End of Treatment (up to 48 weeks)
|
1.06 Log10 IU/L
Standard Deviation 0.903
|
—
|
|
Treatment Arm 1: Actual Values of HBs Antibody Levels
Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
0.82 Log10 IU/L
Standard Deviation 0.718
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBs antibody levels.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=53 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 2: Actual Values of HBs Antibody Levels
At Baseline
|
0.69 Log10 IU/L
Standard Deviation 0.204
|
—
|
|
Treatment Arm 2: Actual Values of HBs Antibody Levels
End of Treatment (up to 36 weeks)
|
0.87 Log10 IU/L
Standard Deviation 0.491
|
—
|
|
Treatment Arm 2: Actual Values of HBs Antibody Levels
Up to 24 weeks off treatment follow-up (study week 36 to week 60)
|
0.80 Log10 IU/L
Standard Deviation 0.521
|
—
|
|
Treatment Arm 2: Actual Values of HBs Antibody Levels
Up to 36 weeks off treatment follow-up (study week 36 to week 72)
|
0.76 Log10 IU/L
Standard Deviation 0.481
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBs antibody levels over time. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=48 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 1: Mean Change From Baseline in HBs Antibody Levels
End of treatment (up to 48 weeks)
|
0.42 Log10 IU/L
Standard Deviation 0.934
|
—
|
|
Treatment Arm 1: Mean Change From Baseline in HBs Antibody Levels
Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
0.18 Log10 IU/L
Standard Deviation 0.757
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess HBs antibody levels over time. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=49 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 2: Mean Change From Baseline in HBs Antibody Levels
End of Treatment (up to 36 weeks)
|
0.18 Log10 IU/L
Standard Deviation 0.450
|
—
|
|
Treatment Arm 2: Mean Change From Baseline in HBs Antibody Levels
Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
0.09 Log10 IU/L
Standard Deviation 0.487
|
—
|
|
Treatment Arm 2: Mean Change From Baseline in HBs Antibody Levels
Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
0.05 Log10 IU/L
Standard Deviation 0.453
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess ALT mean values.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=55 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 1: Actual Values of ALT
At Baseline
|
22.7 International Units Per Liter (IU/L)
Standard Deviation 13.97
|
—
|
|
Treatment Arm 1: Actual Values of ALT
End of Treatment (up to 48 weeks)
|
53.1 International Units Per Liter (IU/L)
Standard Deviation 60.61
|
—
|
|
Treatment Arm 1: Actual Values of ALT
Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
19.2 International Units Per Liter (IU/L)
Standard Deviation 9.77
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess ALT mean values.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=53 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 2: Actual Values of ALT
At Baseline
|
26.9 IU/L
Standard Deviation 19.16
|
—
|
|
Treatment Arm 2: Actual Values of ALT
End of Treatment (up to 36 weeks)
|
55.3 IU/L
Standard Deviation 46.60
|
—
|
|
Treatment Arm 2: Actual Values of ALT
Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
22.1 IU/L
Standard Deviation 13.30
|
—
|
|
Treatment Arm 2: Actual Values of ALT
Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
23.5 IU/L
Standard Deviation 15.61
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess ALT values. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=49 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 1: Change From Baseline in ALT
End of Treatment (up to 48 weeks)
|
27.6 IU/L
Standard Deviation 56.05
|
—
|
|
Treatment Arm 1: Change From Baseline in ALT
Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
|
-3.8 IU/L
Standard Deviation 9.86
|
—
|
SECONDARY outcome
Timeframe: At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Blood samples were collected to assess ALT values. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=49 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 2: Change From Baseline in ALT
End of treatment (up to 36 weeks)
|
27.8 IU/L
Standard Deviation 40.55
|
—
|
|
Treatment Arm 2: Change From Baseline in ALT
Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60)
|
-4.3 IU/L
Standard Deviation 17.50
|
—
|
|
Treatment Arm 2: Change From Baseline in ALT
Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
|
-3.1 IU/L
Standard Deviation 18.65
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeks off treatment (Study Week 48 to72)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Time to ALT normalization in absence of rescue medication were measured in participants having Baseline ALT\>ULN.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=4 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 1 - Median Time to ALT Normalization in Absence of Rescue Medication for 24 Weeks After End of Treatment
|
NA Weeks
Interval 6.3 to
The estimate for Median Time to Event (Weeks) is not estimable (NE) for Arm 1 because the survival curve did not reach below 0.5 at the last timepoint. The corresponding 95% CI's upper limit is NE because the number of events in Arm 1 was too small to provide an estimate.
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeks off treatment (Study Weeks 36 to 60)Population: Intent to Treat (ITT) Set that included all randomized participants. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
Time to ALT normalization in absence of rescue medication were measured in participants having Baseline ALT\>ULN.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=10 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Treatment Arm 2 - Median Time to ALT Normalization in Absence of Rescue Medication for 24 Weeks After End of Treatment
|
4.1 Weeks
Interval 1.1 to 47.1
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeks off treatment (Treatment Arm 1: Study Weeks 48 to 72 and Treatment Arm 2: Study Weeks 36 to 60)Population: Intent to Treat (ITT) Set that included all randomized participants.
Sustained virologic response is defined as undetectable levels of HBsAg and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as Hepatitis B surface antigen (HBsAg) and Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of GSK3228836 treatment which is sustained for 24 weeks post-GSK3228836 treatment in the absence of rescue medication. The point estimate for the difference in SVR and its respective credible interval (CI) were evaluated at 24 weeks off of planned treatment for both arms. The comparison of efficacy is between treatment durations and timepoint corresponds to Week 72 in Arm 1 and Week 60 in Arm 2. 95% CI here refers as credible interval. Percentage values are rounded-off.
Outcome measures
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=55 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
n=53 Participants
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks Off Treatment for Comparison of Efficacy Between Different Treatment Durations
|
9 Percentage of participants
|
15 Percentage of participants
|
Adverse Events
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
Serious events: 6 serious events
Other events: 52 other events
Deaths: 0 deaths
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=55 participants at risk
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
n=53 participants at risk
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Appendicitis
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
COVID-19
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Chest injury
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
Other adverse events
| Measure |
GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks)
n=55 participants at risk
Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
|
GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks)
n=53 participants at risk
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
1.8%
1/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.5%
3/55 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
18.2%
10/55 • Number of events 18 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
13.2%
7/53 • Number of events 10 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.2%
10/55 • Number of events 25 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
22.6%
12/53 • Number of events 21 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.5%
14/55 • Number of events 20 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
20.8%
11/53 • Number of events 16 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
1.8%
1/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
1.8%
1/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Eye disorders
Cataract
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Eye disorders
Dry eye
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Eye disorders
Eye pain
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Eye disorders
Meibomian gland dysfunction
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Eye disorders
Xerophthalmia
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.6%
2/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
1/55 • Number of events 12 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.3%
4/55 • Number of events 8 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
7.5%
4/53 • Number of events 4 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Anal blister
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
7.5%
4/53 • Number of events 5 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
3/55 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
11.3%
6/53 • Number of events 6 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
2/55 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
7.5%
4/53 • Number of events 4 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gingival pain
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Malocclusion
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
14.5%
8/55 • Number of events 14 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
11.3%
6/53 • Number of events 6 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
3.6%
2/55 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
5.7%
3/53 • Number of events 4 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
2/55 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
9.1%
5/55 • Number of events 8 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
18.9%
10/53 • Number of events 21 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Chills
|
5.5%
3/55 • Number of events 5 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Discomfort
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Facial pain
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
16.4%
9/55 • Number of events 19 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
9.4%
5/53 • Number of events 8 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Influenza like illness
|
21.8%
12/55 • Number of events 14 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
15.1%
8/53 • Number of events 12 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Malaise
|
12.7%
7/55 • Number of events 11 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
5.7%
3/53 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Pain
|
3.6%
2/55 • Number of events 7 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
30.9%
17/55 • Number of events 25 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
26.4%
14/53 • Number of events 19 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Vaccination site pain
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
5.5%
3/55 • Number of events 5 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
COVID-19
|
27.3%
15/55 • Number of events 15 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
9.4%
5/53 • Number of events 5 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Chlamydial infection
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Folliculitis
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Gonorrhoea
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Herpes dermatitis
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Hordeolum
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Laryngitis
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Localised infection
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
2/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
9.4%
5/53 • Number of events 7 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Otitis media
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection viral
|
3.6%
2/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
7.5%
4/53 • Number of events 5 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Tonsillitis
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.5%
3/55 • Number of events 4 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Infections and infestations
Viral infection
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Lip injury
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
3.6%
2/55 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 6 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
41.8%
23/55 • Number of events 36 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
11.3%
6/53 • Number of events 9 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Antineutrophil cytoplasmic antibody increased
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Antineutrophil cytoplasmic antibody positive
|
1.8%
1/55 • Number of events 4 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
29.1%
16/55 • Number of events 21 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
11.3%
6/53 • Number of events 6 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
3.6%
2/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Blood phosphorus decreased
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Blood pressure increased
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Body temperature increased
|
5.5%
3/55 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
7.5%
4/53 • Number of events 8 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
C-reactive protein increased
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Complement factor C3 decreased
|
12.7%
7/55 • Number of events 9 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
5.7%
3/53 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Complement factor C4 decreased
|
14.5%
8/55 • Number of events 11 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Complement fragment Bb increased
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Creatinine renal clearance decreased
|
10.9%
6/55 • Number of events 35 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
7.5%
4/53 • Number of events 24 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Creatinine renal clearance increased
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Glomerular filtration rate decreased
|
3.6%
2/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Hepatitis B DNA increased
|
3.6%
2/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Monocyte chemotactic protein-1 increased
|
3.6%
2/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
25.5%
14/55 • Number of events 22 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
15.1%
8/53 • Number of events 12 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Platelet count decreased
|
18.2%
10/55 • Number of events 13 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
9.4%
5/53 • Number of events 5 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Red blood cell count decreased
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Thyroxine increased
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Transaminases increased
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 5 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
Weight decreased
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
14.5%
8/55 • Number of events 14 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
7.5%
4/53 • Number of events 7 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Cell death
|
3.6%
2/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.7%
7/55 • Number of events 7 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
7.5%
4/53 • Number of events 4 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
4/55 • Number of events 5 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
17.0%
9/53 • Number of events 13 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.5%
3/55 • Number of events 9 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
7.5%
4/53 • Number of events 5 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.6%
2/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Hip deformity
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 4 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.9%
6/55 • Number of events 9 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
22.6%
12/53 • Number of events 25 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 7 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
5.5%
3/55 • Number of events 4 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
7.5%
4/53 • Number of events 4 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
12.7%
7/55 • Number of events 29 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
22.6%
12/53 • Number of events 25 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
1.8%
1/55 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Nervous system disorders
Migraine
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Nervous system disorders
Muscle contractions involuntary
|
3.6%
2/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Nervous system disorders
Sensory disturbance
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Nervous system disorders
Somnolence
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 8 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Nervous system disorders
Tremor
|
1.8%
1/55 • Number of events 11 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Psychiatric disorders
Depressed mood
|
3.6%
2/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Psychiatric disorders
Depression
|
3.6%
2/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Psychiatric disorders
Hyposomnia
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
7.5%
4/53 • Number of events 6 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Psychiatric disorders
Irritability
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
5.7%
3/53 • Number of events 4 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Psychiatric disorders
Libido decreased
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Psychiatric disorders
Mood altered
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Psychiatric disorders
Nervousness
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal impairment
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Breast swelling
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
1.8%
1/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Prostatitis
|
1.8%
1/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal discomfort
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.6%
2/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.5%
3/55 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
11.3%
6/53 • Number of events 6 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.6%
2/55 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
5.7%
3/53 • Number of events 3 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
5/55 • Number of events 5 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 5 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.5%
3/55 • Number of events 5 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
1.8%
1/55 • Number of events 7 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/55 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Injection site anaesthesia
|
1.8%
1/55 • Number of events 2 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Injection site bruising
|
3.6%
2/55 • Number of events 13 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
7.5%
4/53 • Number of events 7 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Injection site discolouration
|
9.1%
5/55 • Number of events 17 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
5.7%
3/53 • Number of events 12 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Injection site discomfort
|
1.8%
1/55 • Number of events 38 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
3.8%
2/53 • Number of events 5 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Injection site erythema
|
36.4%
20/55 • Number of events 112 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
41.5%
22/53 • Number of events 208 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Injection site haematoma
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
0.00%
0/53 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Injection site haemorrhage
|
3.6%
2/55 • Number of events 4 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Injection site induration
|
12.7%
7/55 • Number of events 9 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
5.7%
3/53 • Number of events 17 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Injection site nodule
|
1.8%
1/55 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
1.9%
1/53 • Number of events 1 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Injection site pain
|
12.7%
7/55 • Number of events 56 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
20.8%
11/53 • Number of events 102 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Injection site pruritus
|
18.2%
10/55 • Number of events 36 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
20.8%
11/53 • Number of events 118 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Injection site swelling
|
3.6%
2/55 • Number of events 8 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
9.4%
5/53 • Number of events 32 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
|
General disorders
Injection site warmth
|
1.8%
1/55 • Number of events 44 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
5.7%
3/53 • Number of events 77 • Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER