Trial Outcomes & Findings for Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B (China) (NCT NCT02836236)
NCT ID: NCT02836236
Last Updated: 2024-10-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
155 participants
Primary outcome timeframe
Week 48
Results posted on
2024-10-02
Participant Flow
Participants were enrolled at the study sites in China.
236 participants were screened in China.
Participant milestones
| Measure |
Double-Blind: TAF 25 mg
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablets administered once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind: TDF 300 mg
TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks (per amendment 3.1).
|
Open-label: TAF 25 mg to TAF 25 mg
After Week 144 in the Blinded Treatment Phase, participants were given the option to continue with Open-label (OL) TAF 25 mg for additional 240 weeks (Up to Week 384).
|
Open-label: TDF 300 mg to TAF 25 mg
After Week 144 in the Blinded Treatment Phase, participants were given the option to switch to OL TAF 25 mg for additional 240 weeks (Up to Week 384).
|
|---|---|---|---|---|
|
Double-Blind Treatment Phase
STARTED
|
105
|
50
|
0
|
0
|
|
Double-Blind Treatment Phase
COMPLETED
|
99
|
47
|
0
|
0
|
|
Double-Blind Treatment Phase
NOT COMPLETED
|
6
|
3
|
0
|
0
|
|
Open-Label TAF Treatment Phase
STARTED
|
0
|
0
|
99
|
47
|
|
Open-Label TAF Treatment Phase
COMPLETED
|
0
|
0
|
92
|
43
|
|
Open-Label TAF Treatment Phase
NOT COMPLETED
|
0
|
0
|
7
|
4
|
Reasons for withdrawal
| Measure |
Double-Blind: TAF 25 mg
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablets administered once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind: TDF 300 mg
TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks (per amendment 3.1).
|
Open-label: TAF 25 mg to TAF 25 mg
After Week 144 in the Blinded Treatment Phase, participants were given the option to continue with Open-label (OL) TAF 25 mg for additional 240 weeks (Up to Week 384).
|
Open-label: TDF 300 mg to TAF 25 mg
After Week 144 in the Blinded Treatment Phase, participants were given the option to switch to OL TAF 25 mg for additional 240 weeks (Up to Week 384).
|
|---|---|---|---|---|
|
Double-Blind Treatment Phase
Withdrew Consent
|
3
|
1
|
0
|
0
|
|
Double-Blind Treatment Phase
Investigator's Discretion
|
2
|
1
|
0
|
0
|
|
Double-Blind Treatment Phase
Adverse Event
|
0
|
1
|
0
|
0
|
|
Double-Blind Treatment Phase
Randomized but Never Treated
|
1
|
0
|
0
|
0
|
|
Open-Label TAF Treatment Phase
Withdrew consent
|
0
|
0
|
3
|
2
|
|
Open-Label TAF Treatment Phase
Lost to Follow-up
|
0
|
0
|
2
|
1
|
|
Open-Label TAF Treatment Phase
Death
|
0
|
0
|
1
|
1
|
|
Open-Label TAF Treatment Phase
Investigator's discretion
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B (China)
Baseline characteristics by cohort
| Measure |
Double-Blind Treatment Phase: TAF 25 mg
n=104 Participants
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablets administered once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind Treatment Phase: TDF 300 mg
n=50 Participants
TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks (per amendment 3.1).
|
Total
n=154 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
|
102 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
45 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
43 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
104 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
104 count of participants
n=5 Participants
|
50 count of participants
n=7 Participants
|
154 count of participants
n=5 Participants
|
|
HBV DNA
|
5.5 log10 IU/mL
STANDARD_DEVIATION 1.73 • n=5 Participants
|
5.3 log10 IU/mL
STANDARD_DEVIATION 1.63 • n=7 Participants
|
5.5 log10 IU/mL
STANDARD_DEVIATION 1.70 • n=5 Participants
|
|
Plasma HBV DNA Level
< 7 log10 IU/mL
|
77 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Plasma HBV DNA Level
≥ 7 log10 IU/mL to < 8 log10 IU/mL
|
21 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Plasma HBV DNA Level
≥ 8 log10 IU/mL
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
IL28b Status
CC
|
94 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
IL28b Status
CT
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
IL28b Status
TT
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
IL28b Status
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Oral antiviral (OAV) Treatment Status
Treatment Experienced
|
41 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Oral antiviral (OAV) Treatment Status
Treatment Naive
|
63 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Proteinuria by Urinalysis (dipstick)
Grade 0
|
101 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Proteinuria by Urinalysis (dipstick)
Grade 1
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Proteinuria by Urinalysis (dipstick)
Grade 2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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.
Outcome measures
| Measure |
Double-Blind Treatment Phase: TAF 25 mg
n=104 Participants
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablets administered once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind Treatment Phase: TDF 300 mg
n=50 Participants
TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks (per amendment 3.1).
|
|---|---|---|
|
Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48
|
89.4 percentage of participants
|
98.0 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 |
Double-Blind Treatment Phase: TAF 25 mg
n=39 Participants
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablets administered once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind Treatment Phase: TDF 300 mg
n=22 Participants
TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks (per amendment 3.1).
|
|---|---|---|
|
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
|
-0.718 percent change
Standard Deviation 2.0131
|
-1.096 percent change
Standard Deviation 2.9200
|
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. Dual-energy x ray absorptiometry scans were performed only at sites in China with capability. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.
Outcome measures
| Measure |
Double-Blind Treatment Phase: TAF 25 mg
n=39 Participants
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablets administered once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind Treatment Phase: TDF 300 mg
n=22 Participants
TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks (per amendment 3.1).
|
|---|---|---|
|
Percent Change From Baseline in Spine BMD at Week 48
|
0.740 percent change
Standard Deviation 3.3764
|
-3.456 percent change
Standard Deviation 3.1071
|
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 were excluded from analysis.
Outcome measures
| Measure |
Double-Blind Treatment Phase: TAF 25 mg
n=101 Participants
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablets administered once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind Treatment Phase: TDF 300 mg
n=49 Participants
TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks (per amendment 3.1).
|
|---|---|---|
|
Change From Baseline in Serum Creatinine at Week 48
|
0.012 mg/dL
Standard Deviation 0.0827
|
0.030 mg/dL
Standard Deviation 0.0754
|
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 |
Double-Blind Treatment Phase: TAF 25 mg
n=102 Participants
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablets administered once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind Treatment Phase: TDF 300 mg
n=50 Participants
TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks (per amendment 3.1).
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48
Grade 1
|
21.6 percentage of participants
|
18.0 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48
Grade 2
|
2.9 percentage of participants
|
4.0 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 Treatment Phase: TAF 25 mg
Serious events: 11 serious events
Other events: 87 other events
Deaths: 0 deaths
Double-Blind Treatment Phase: TDF 300 mg
Serious events: 7 serious events
Other events: 45 other events
Deaths: 0 deaths
Open-Label Treatment Phase: TAF From TAF
Serious events: 20 serious events
Other events: 81 other events
Deaths: 1 deaths
Open-Label Treatment Phase: TAF From TDF
Serious events: 7 serious events
Other events: 39 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Double-Blind Treatment Phase: TAF 25 mg
n=104 participants at risk
Tenofovir alafenamide (TAF) 25 mg + tenofovir disoproxil fumarate (TDF) placebo tablets administered once daily for up to 144 weeks
|
Double-Blind Treatment Phase: TDF 300 mg
n=50 participants at risk
TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks
|
Open-Label Treatment Phase: TAF From TAF
n=99 participants at risk
After Week 144 in the Blinded Treatment Phase, participants were given the option to continue with Open-label (OL) TAF 25 mg for additional 240 weeks (Up to Week 384).
|
Open-Label Treatment Phase: TAF From TDF
n=47 participants at risk
After Week 144 in the Blinded Treatment Phase, participants were given the option to switch to Open-label (OL) TAF 25 mg for additional 240 weeks (Up to Week 384).
|
|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Appendicitis noninfective
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
1/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
3.0%
3/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
1/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
3.0%
3/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.0%
2/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.0%
2/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
1/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
1/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Chronic hepatitis B
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
1/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
2/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
1/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
2/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
1/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
1/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
1/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
1/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.3%
2/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic cystadenoma
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
1/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
1/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
1/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mass
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Vascular disorders
Ischaemia
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Double-Blind Treatment Phase: TAF 25 mg
n=104 participants at risk
Tenofovir alafenamide (TAF) 25 mg + tenofovir disoproxil fumarate (TDF) placebo tablets administered once daily for up to 144 weeks
|
Double-Blind Treatment Phase: TDF 300 mg
n=50 participants at risk
TDF 300 mg + TAF placebo tablets administered once daily for up to 144 weeks
|
Open-Label Treatment Phase: TAF From TAF
n=99 participants at risk
After Week 144 in the Blinded Treatment Phase, participants were given the option to continue with Open-label (OL) TAF 25 mg for additional 240 weeks (Up to Week 384).
|
Open-Label Treatment Phase: TAF From TDF
n=47 participants at risk
After Week 144 in the Blinded Treatment Phase, participants were given the option to switch to Open-label (OL) TAF 25 mg for additional 240 weeks (Up to Week 384).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
2.9%
3/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
8.0%
4/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
2/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.3%
2/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.7%
9/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
10.0%
5/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.0%
4/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
1/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.0%
3/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
3.0%
3/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
1/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
8/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
8.0%
4/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
5.1%
5/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
1/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
2/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
8.0%
4/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
2.9%
3/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
12.0%
6/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
2/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
General disorders
Chest discomfort
|
5.8%
6/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.0%
2/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
3.0%
3/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
1/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
5.8%
6/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
1/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
1/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
5.1%
5/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
1/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.0%
2/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
3.0%
3/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
8.5%
4/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
1.9%
2/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
7.1%
7/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
8.5%
4/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.4%
3/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
4.8%
5/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.0%
3/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
29.3%
29/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
19.1%
9/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Covid-19
|
0.00%
0/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
39.4%
39/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
34.0%
16/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
3.8%
4/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
10.0%
5/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
1/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
30.8%
32/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
24.0%
12/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
13.1%
13/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
8.5%
4/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
4.8%
5/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
8.0%
4/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
1/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
24.0%
25/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
22.0%
11/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
20.2%
20/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.4%
3/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
4.8%
5/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.1%
6/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.1%
1/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Investigations
Amylase increased
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.0%
3/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
1.0%
1/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Investigations
Blood glucose increased
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.0%
2/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.0%
4/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.4%
3/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Investigations
Blood parathyroid hormone increased
|
1.9%
2/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
10.0%
5/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.0%
4/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.4%
3/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Investigations
Protein urine present
|
2.9%
3/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.0%
2/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.1%
6/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.3%
2/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
1.9%
2/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
12.0%
6/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.0%
4/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.3%
2/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.0%
3/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.9%
2/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
5.1%
5/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.3%
2/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.8%
4/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.0%
3/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
17.2%
17/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
10.6%
5/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.8%
4/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.0%
3/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
5.1%
5/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.3%
2/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
5/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
1/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
2/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.4%
3/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
4/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
1/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
5.1%
5/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.3%
2/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.0%
3/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
2/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.3%
2/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
8.1%
8/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.3%
2/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
7.7%
8/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.0%
2/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.96%
1/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
1/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.0%
4/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
6.4%
3/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
16/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.0%
2/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
8.1%
8/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
0.00%
0/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.7%
9/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
10.0%
5/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
3.0%
3/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
4.3%
2/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
1.9%
2/104 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
2.0%
1/50 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
12.1%
12/99 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
10.6%
5/47 • All-cause mortality: Up to 402 weeks; Adverse events: Up to Week 384
All-cause mortality: The Randomized Analysis Set included all participants who were randomized into the study. Adverse events: The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
|
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