Trial Outcomes & Findings for Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen (NCT NCT01940341)
NCT ID: NCT01940341
Last Updated: 2023-09-25
Results Overview
The primary efficacy endpoint was determined by the achievement of HBV DNA \< 29 IU/mL at Week 48.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
426 participants
Primary outcome timeframe
Week 48
Results posted on
2023-09-25
Participant Flow
Participants were enrolled at study sites in East Asia, Europe, North America, Australia, India, and New Zealand.
877 participants were screened.
Participant milestones
| Measure |
TAF 25 mg
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg + tenofovir disoproxil fumarate (TDF) placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
TDF 300 mg
TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
TAF 25 mg to TAF 25 mg
After Week 96 or 144 in the Blinded Treatment Phase, participants were given the option to continue with Open-label (OL) TAF 25 mg for additional 288 or 240 weeks (Up to Week 384), respectively.
After the completion of OL TAF Extension Phase treatment or when there was early discontinuation of treatment, participants either switched to commercially available anti-HBV treatments in their country or entered follow-up phase and were followed-up every 4 weeks for 24 weeks off treatment (treatment-free follow-up \[TFFU\]) for the assessment of safety.
|
TDF 300 mg to TAF 25 mg
After Week 96 or 144 in the Blinded Treatment Phase, participants were given the option to switch to OL TAF 25 mg for additional 288 or 240 weeks (Up to Week 384), respectively.
After the completion of OL TAF Extension Phase treatment or when there was early discontinuation of treatment, participants either switched to commercially available anti-HBV treatments in their country or entered follow-up phase and were followed-up every 4 weeks for 24 weeks off treatment (TFFU) for the assessment of safety.
|
|---|---|---|---|---|
|
Period 1: Double-blind Phase
STARTED
|
285
|
141
|
0
|
0
|
|
Period 1: Double-blind Phase
COMPLETED
|
261
|
129
|
0
|
0
|
|
Period 1: Double-blind Phase
NOT COMPLETED
|
24
|
12
|
0
|
0
|
|
Period 2: Open-Label TAF Extension Phase
STARTED
|
0
|
0
|
261
|
129
|
|
Period 2: Open-Label TAF Extension Phase
COMPLETED
|
0
|
0
|
227
|
118
|
|
Period 2: Open-Label TAF Extension Phase
NOT COMPLETED
|
0
|
0
|
34
|
11
|
Reasons for withdrawal
| Measure |
TAF 25 mg
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg + tenofovir disoproxil fumarate (TDF) placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
TDF 300 mg
TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
TAF 25 mg to TAF 25 mg
After Week 96 or 144 in the Blinded Treatment Phase, participants were given the option to continue with Open-label (OL) TAF 25 mg for additional 288 or 240 weeks (Up to Week 384), respectively.
After the completion of OL TAF Extension Phase treatment or when there was early discontinuation of treatment, participants either switched to commercially available anti-HBV treatments in their country or entered follow-up phase and were followed-up every 4 weeks for 24 weeks off treatment (treatment-free follow-up \[TFFU\]) for the assessment of safety.
|
TDF 300 mg to TAF 25 mg
After Week 96 or 144 in the Blinded Treatment Phase, participants were given the option to switch to OL TAF 25 mg for additional 288 or 240 weeks (Up to Week 384), respectively.
After the completion of OL TAF Extension Phase treatment or when there was early discontinuation of treatment, participants either switched to commercially available anti-HBV treatments in their country or entered follow-up phase and were followed-up every 4 weeks for 24 weeks off treatment (TFFU) for the assessment of safety.
|
|---|---|---|---|---|
|
Period 1: Double-blind Phase
Withdrew Consent
|
7
|
4
|
0
|
0
|
|
Period 1: Double-blind Phase
Lost to Follow-up
|
8
|
1
|
0
|
0
|
|
Period 1: Double-blind Phase
Adverse Event
|
4
|
2
|
0
|
0
|
|
Period 1: Double-blind Phase
Investigator's Discretion
|
3
|
1
|
0
|
0
|
|
Period 1: Double-blind Phase
Non-compliance with Study Drug
|
1
|
1
|
0
|
0
|
|
Period 1: Double-blind Phase
Death
|
0
|
1
|
0
|
0
|
|
Period 1: Double-blind Phase
Pregnancy
|
0
|
1
|
0
|
0
|
|
Period 1: Double-blind Phase
Protocol Specified Criteria for Withdrawal
|
1
|
0
|
0
|
0
|
|
Period 1: Double-blind Phase
Randomized but Never Treated
|
0
|
1
|
0
|
0
|
|
Period 2: Open-Label TAF Extension Phase
Withdrew Consent
|
0
|
0
|
17
|
4
|
|
Period 2: Open-Label TAF Extension Phase
Investigator's Discretion
|
0
|
0
|
3
|
4
|
|
Period 2: Open-Label TAF Extension Phase
Lost to Follow-up
|
0
|
0
|
6
|
0
|
|
Period 2: Open-Label TAF Extension Phase
Protocol Specified Criteria for Withdrawal
|
0
|
0
|
3
|
1
|
|
Period 2: Open-Label TAF Extension Phase
Adverse Event
|
0
|
0
|
2
|
0
|
|
Period 2: Open-Label TAF Extension Phase
Death
|
0
|
0
|
1
|
0
|
|
Period 2: Open-Label TAF Extension Phase
HbsAg Seroconversion
|
0
|
0
|
1
|
0
|
|
Period 2: Open-Label TAF Extension Phase
Non-compliance with Study Drug
|
0
|
0
|
0
|
1
|
|
Period 2: Open-Label TAF Extension Phase
Pregnancy
|
0
|
0
|
0
|
1
|
|
Period 2: Open-Label TAF Extension Phase
Progressive Disease
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen
Baseline characteristics by cohort
| Measure |
TAF 25 mg
n=285 Participants
Double-blind Phase: Tenofovir alafenamide (Vemlidy®; TAF) 25 mg + tenofovir disoproxil fumarate (TDF) placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
Open-label TAF extension Phase: After Week 96 or 144 in the Blinded Treatment Phase, participants were given the option to continue with OL TAF 25 mg for additional 288 or 240 weeks (Up to Week 384), respectively.
After the completion of OL TAF Extension Phase treatment or when there was early discontinuation of treatment, participants either switched to commercially available anti-HBV treatments in their country or entered follow-up phase and were followed-up every 4 weeks for 24 weeks off treatment (TFFU) for the assessment of safety.
|
TDF 300 mg
n=140 Participants
Double-blind Phase: TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
Open-label TAF extension Phase: After Week 96 or 144 in the Blinded Treatment Phase, participants were given the option to continue with OL TAF 25 mg for additional 288 or 240 weeks (Up to Week 384), respectively.
After the completion of OL TAF Extension Phase treatment or when there was early discontinuation of treatment, participants either switched to commercially available anti-HBV treatments in their country or entered follow-up phase and were followed-up every 4 weeks for 24 weeks off treatment (TFFU) for the assessment of safety.
|
Total
n=425 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
276 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
412 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
48 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
46 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
173 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
279 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
419 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
205 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
71 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other or More Than One Race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
41 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
29 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
30 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
22 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
22 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
26 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
21 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
IL28b Status
CC
|
209 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
315 Participants
n=5 Participants
|
|
IL28b Status
CT
|
65 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
IL28b Status
TT
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
IL28b Status
Missing
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
HBV DNA
|
5.7 Log10 IU/mL
STANDARD_DEVIATION 1.34 • n=5 Participants
|
5.8 Log10 IU/mL
STANDARD_DEVIATION 1.32 • n=7 Participants
|
5.8 Log10 IU/mL
STANDARD_DEVIATION 1.33 • n=5 Participants
|
|
Plasma HBV DNA Level
< 7 log10 IU/mL
|
230 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
346 Participants
n=5 Participants
|
|
Plasma HBV DNA Level
≥ 7 log10 IU/mL - < 8 log10 IU/mL
|
42 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Plasma HBV DNA Level
≥ 8 log10 IU/mL
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Oral antiviral (OAV) treatment status
Treatment Experienced
|
60 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Oral antiviral (OAV) treatment status
Treatment Naive
|
225 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
334 Participants
n=5 Participants
|
|
Proteinuria by Urinalysis (dipstick)
Grade 0
|
270 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
405 Participants
n=5 Participants
|
|
Proteinuria by Urinalysis (dipstick)
Grade 1
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Proteinuria by Urinalysis (dipstick)
Grade 2
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Proteinuria by Urinalysis (dipstick)
Grade 3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Full Analysis set: participants who were randomized into the study and received at least 1 dose of study drugs. Participants were analyzed according to the treatment to which they were randomized.
The primary efficacy endpoint was determined by the achievement of HBV DNA \< 29 IU/mL at Week 48.
Outcome measures
| Measure |
TAF 25 mg
n=285 Participants
TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
TDF 300 mg
n=140 Participants
TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
|---|---|---|
|
Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL
|
94.0 Percentage of participants
|
92.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants in the Hip Dual-Energy X-ray Absorptiometry (DXA) Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline hip BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.
Outcome measures
| Measure |
TAF 25 mg
n=270 Participants
TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
TDF 300 mg
n=133 Participants
TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
|---|---|---|
|
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
|
-0.288 percentage change
Standard Deviation 2.1448
|
-2.156 percentage change
Standard Deviation 2.1672
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants in the Spine DXA Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline spine BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data was excluded from analysis.
Outcome measures
| Measure |
TAF 25 mg
n=271 Participants
TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
TDF 300 mg
n=133 Participants
TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
|---|---|---|
|
Percent Change From Baseline in Spine BMD at Week 48
|
-0.876 percentage change
Standard Deviation 2.8558
|
-2.514 percentage change
Standard Deviation 3.3558
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants in the Safety Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data was excluded from analysis.
Outcome measures
| Measure |
TAF 25 mg
n=275 Participants
TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
TDF 300 mg
n=135 Participants
TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
|---|---|---|
|
Change From Baseline in Serum Creatinine at Week 48
|
0.01 mg/dL
Standard Deviation 0.091
|
0.02 mg/dL
Standard Deviation 0.103
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 48 weeksPopulation: Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.
Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method.
Outcome measures
| Measure |
TAF 25 mg
n=282 Participants
TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
TDF 300 mg
n=140 Participants
TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48
Grade 1
|
18.1 percentage of participants
|
16.4 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48
Grade 2
|
1.1 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48
Grade 3
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Double-blind Phase: TAF 25 mg
Serious events: 26 serious events
Other events: 178 other events
Deaths: 0 deaths
Double-blind Phase: TDF 300 mg
Serious events: 17 serious events
Other events: 89 other events
Deaths: 2 deaths
Open-label TAF Extension Phase: TAF 25 mg to TAF 25 mg
Serious events: 38 serious events
Other events: 112 other events
Deaths: 1 deaths
Open-label TAF Extension Phase: TDF 300 mg to TAF 25 mg
Serious events: 17 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-blind Phase: TAF 25 mg
n=285 participants at risk
TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
Double-blind Phase: TDF 300 mg
n=140 participants at risk
TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
Open-label TAF Extension Phase: TAF 25 mg to TAF 25 mg
n=261 participants at risk
After Week 96 or 144 in the Blinded Treatment Phase, participants were given the option to continue with OL TAF 25 mg for additional 288 or 240 weeks (Up to Week 384).
After the completion of OL TAF Extension Phase treatment or when there was early discontinuation of treatment, participants either switched to commercially available anti-HBV treatments in their country or entered follow-up phase and were followed-up every 4 weeks for 24 weeks off treatment (TFFU) for the assessment of safety.
|
Open-label TAF Extension Phase: TDF 300 mg to TAF 25 mg
n=129 participants at risk
After Week 96 or 144 in the Blinded Treatment Phase, participants were given the option to switch to Open-label (OL) TAF 25 mg for additional 288 or 240 weeks (Up to Week 384).
After the completion of OL TAF Extension Phase treatment or when there was early discontinuation of treatment, participants either switched to commercially available anti-HBV treatments in their country or entered follow-up phase and were followed-up every 4 weeks for 24 weeks off treatment (TFFU) for the assessment of safety.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.71%
1/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.77%
2/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
1.6%
2/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.77%
2/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.77%
2/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.71%
1/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.71%
1/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
General disorders
Chest discomfort
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
General disorders
Chest pain
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
General disorders
Pyrexia
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.77%
2/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.71%
1/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
1.4%
2/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Infections and infestations
Plasmodium vivax infection
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Infections and infestations
Pneumonia
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.71%
1/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
1.6%
2/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.71%
1/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.71%
1/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.71%
1/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.71%
1/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Metabolism and nutrition disorders
Gout
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.71%
1/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.71%
1/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.70%
2/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
2.9%
4/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
2.3%
6/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
2.3%
3/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.70%
2/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.71%
1/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Product Issues
Device breakage
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Product Issues
Device dislocation
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
1.4%
2/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Renal and urinary disorders
Haematuria
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.77%
2/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Renal and urinary disorders
Renal colic
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.70%
2/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.38%
1/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.71%
1/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Vascular disorders
Hypertension
|
0.35%
1/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.00%
0/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
Other adverse events
| Measure |
Double-blind Phase: TAF 25 mg
n=285 participants at risk
TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
Double-blind Phase: TDF 300 mg
n=140 participants at risk
TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).
|
Open-label TAF Extension Phase: TAF 25 mg to TAF 25 mg
n=261 participants at risk
After Week 96 or 144 in the Blinded Treatment Phase, participants were given the option to continue with OL TAF 25 mg for additional 288 or 240 weeks (Up to Week 384).
After the completion of OL TAF Extension Phase treatment or when there was early discontinuation of treatment, participants either switched to commercially available anti-HBV treatments in their country or entered follow-up phase and were followed-up every 4 weeks for 24 weeks off treatment (TFFU) for the assessment of safety.
|
Open-label TAF Extension Phase: TDF 300 mg to TAF 25 mg
n=129 participants at risk
After Week 96 or 144 in the Blinded Treatment Phase, participants were given the option to switch to Open-label (OL) TAF 25 mg for additional 288 or 240 weeks (Up to Week 384).
After the completion of OL TAF Extension Phase treatment or when there was early discontinuation of treatment, participants either switched to commercially available anti-HBV treatments in their country or entered follow-up phase and were followed-up every 4 weeks for 24 weeks off treatment (TFFU) for the assessment of safety.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
14.0%
40/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
13.6%
19/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
7.3%
19/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
7.8%
10/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Infections and infestations
Pharyngitis
|
4.2%
12/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
2.9%
4/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
5.4%
14/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
3.1%
4/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
15/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
2.1%
3/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
3.4%
9/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
2.3%
3/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
17/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
3.6%
5/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
4.2%
11/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
5.4%
7/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.9%
11/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
5.7%
8/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
3.4%
9/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
2.3%
3/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.1%
3/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
2.1%
3/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
5.7%
15/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
1.6%
2/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Gastrointestinal disorders
Nausea
|
6.3%
18/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
7.1%
10/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
1.9%
5/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
General disorders
Fatigue
|
6.0%
17/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
7.1%
10/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
1.9%
5/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
3.1%
4/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Infections and infestations
Influenza
|
6.3%
18/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
6.4%
9/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
5.0%
13/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
0.78%
1/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.3%
38/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
11.4%
16/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
8.8%
23/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
7.8%
10/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Infections and infestations
Urinary tract infection
|
3.2%
9/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
5.7%
8/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
3.4%
9/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
4.7%
6/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
30/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
12.1%
17/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
6.1%
16/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
6.2%
8/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
19/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
5.0%
7/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
5.0%
13/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
7.8%
10/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.6%
13/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
5.0%
7/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
3.4%
9/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
2.3%
3/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Nervous system disorders
Dizziness
|
2.8%
8/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
5.0%
7/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
3.8%
10/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
3.1%
4/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Nervous system disorders
Headache
|
18.6%
53/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
10.7%
15/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
10.3%
27/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
7.8%
10/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
25/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
8.6%
12/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
5.0%
13/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
6.2%
8/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
|
Vascular disorders
Hypertension
|
2.8%
8/285 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
6.4%
9/140 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
5.7%
15/261 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
8.5%
11/129 • All-Cause Mortality: Randomization up to approximately 427.6 weeks Adverse Events: First dose date up to Week 384
All-cause mortality: Randomized Analysis Set: All participants randomized into the study. Adverse events: Safety Analysis Set: Participants who received at least 1 dose of study drug in the respective period.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER