Trial Outcomes & Findings for Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive Hepatitis B (China) (NCT NCT02836249)
NCT ID: NCT02836249
Last Updated: 2024-10-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
181 participants
Primary outcome timeframe
Week 48
Results posted on
2024-10-15
Participant Flow
Participants were enrolled at study sites in China.
226 participants were screened in China.
Participant milestones
| Measure |
Double-Blind: TAF 25 mg
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind: TDF 300 mg
TDF 300 mg tablet + TAF placebo tablet 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
|
123
|
58
|
0
|
0
|
|
Double-Blind Treatment Phase
COMPLETED
|
114
|
52
|
0
|
0
|
|
Double-Blind Treatment Phase
NOT COMPLETED
|
9
|
6
|
0
|
0
|
|
Open-Label TAF Treatment Phase
STARTED
|
0
|
0
|
113
|
52
|
|
Open-Label TAF Treatment Phase
COMPLETED
|
0
|
0
|
100
|
48
|
|
Open-Label TAF Treatment Phase
NOT COMPLETED
|
0
|
0
|
13
|
4
|
Reasons for withdrawal
| Measure |
Double-Blind: TAF 25 mg
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind: TDF 300 mg
TDF 300 mg tablet + TAF placebo tablet 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
Randomized but Never Treated
|
0
|
1
|
0
|
0
|
|
Double-Blind Treatment Phase
Pregnancy
|
3
|
1
|
0
|
0
|
|
Double-Blind Treatment Phase
Withdrew Consent
|
5
|
2
|
0
|
0
|
|
Double-Blind Treatment Phase
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Double-Blind Treatment Phase
Investigator's discretion
|
0
|
1
|
0
|
0
|
|
Double-Blind Treatment Phase
Non-compliance with study drug
|
1
|
0
|
0
|
0
|
|
Open-Label TAF Treatment Phase
Lost to Follow-up
|
0
|
0
|
6
|
1
|
|
Open-Label TAF Treatment Phase
Withdrew consent
|
0
|
0
|
4
|
3
|
|
Open-Label TAF Treatment Phase
Death
|
0
|
0
|
1
|
0
|
|
Open-Label TAF Treatment Phase
Lack of Efficacy
|
0
|
0
|
1
|
0
|
|
Open-Label TAF Treatment Phase
Pregnancy
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive Hepatitis B (China)
Baseline characteristics by cohort
| Measure |
Double-Blind: TAF 25 mg
n=123 Participants
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind: TDF 300 mg
n=57 Participants
TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
121 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
36 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
34 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
132 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
|
123 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
180 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
|
123 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
HBV DNA
|
7.2 log10 IU/mL
STANDARD_DEVIATION 1.65 • n=5 Participants
|
7.2 log10 IU/mL
STANDARD_DEVIATION 1.48 • n=7 Participants
|
7.2 log10 IU/mL
STANDARD_DEVIATION 1.59 • n=5 Participants
|
|
Plasma HBV DNA Level
< 8 log10 IU/mL
|
74 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Plasma HBV DNA Level
≥ 8 log10 IU/mL
|
49 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
IL28b Status
CC
|
109 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
IL28b Status
CT
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
IL28b Status
TT
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Oral antiviral (OAV) Treatment Status
Treatment Experienced
|
45 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Oral antiviral (OAV) Treatment Status
Treatment Naive
|
78 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Proteinuria by Urinalysis (dipstick)
Grade 0
|
117 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Proteinuria by Urinalysis (dipstick)
Grade 1
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Proteinuria by Urinalysis (dipstick)
Grade 2
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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: TAF 25 mg
n=123 Participants
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind: TDF 300 mg
n=57 Participants
TDF 300 mg tablet + TAF placebo tablet 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
|
61.0 percentage of participants
|
68.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Serologically Evaluable Full Analysis Set: participants who were randomized, had received at least 1 dose of study drug, and were HBeAg positive and anti-HBe negative or had a value missing value at baseline. Participants were analyzed according to their randomized treatment group. All missing data were treated as no HBeAg seroconversion.
Outcome measures
| Measure |
Double-Blind: TAF 25 mg
n=118 Participants
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind: TDF 300 mg
n=57 Participants
TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
|---|---|---|
|
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48
|
11.0 percentage of participants
|
8.8 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: TAF 25 mg
n=53 Participants
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind: TDF 300 mg
n=31 Participants
TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
|---|---|---|
|
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
|
0.624 percent change
Standard Deviation 2.2731
|
-1.507 percent change
Standard Deviation 2.4193
|
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: TAF 25 mg
n=54 Participants
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind: TDF 300 mg
n=31 Participants
TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
|---|---|---|
|
Percent Change From Baseline in Spine BMD at Week 48
|
0.683 percent change
Standard Deviation 3.3281
|
-2.169 percent change
Standard Deviation 3.4503
|
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: TAF 25 mg
n=121 Participants
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind: TDF 300 mg
n=55 Participants
TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
|---|---|---|
|
Change From Baseline at Week 48 in Serum Creatinine
|
-0.003 mg/dL
Standard Deviation 0.0701
|
0.016 mg/dL
Standard Deviation 0.0920
|
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: TAF 25 mg
n=123 Participants
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind: TDF 300 mg
n=57 Participants
TDF 300 mg tablet + TAF placebo tablet 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
|
24.4 percentage of participants
|
22.8 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48
Grade 2
|
0.8 percentage of participants
|
3.5 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: TAF 25 mg
Serious events: 8 serious events
Other events: 85 other events
Deaths: 0 deaths
Double-Blind: TDF 300 mg
Serious events: 3 serious events
Other events: 43 other events
Deaths: 0 deaths
Open-label TAF Extension Phase: TAF 25 mg to TAF 25 mg
Serious events: 7 serious events
Other events: 84 other events
Deaths: 1 deaths
Open-label TAF Extension Phase: TDF 300 mg to TAF 25 mg
Serious events: 4 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-Blind: TAF 25 mg
n=123 participants at risk
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind: TDF 300 mg
n=57 participants at risk
TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
Open-label TAF Extension Phase: TAF 25 mg to TAF 25 mg
n=113 participants at risk
After Week 144 in the Blinded Treatment Phase, participants were given the option to continue with OL TAF 25 mg for additional 240 weeks (Up to Week 384).
|
Open-label TAF Extension Phase: TDF 300 mg to TAF 25 mg
n=52 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
Cardiac polyp
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.88%
1/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.88%
1/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.88%
1/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.8%
1/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
General disorders
Pyrexia
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.9%
1/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.88%
1/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.81%
1/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.88%
1/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Infections and infestations
Appendicitis
|
0.81%
1/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.9%
1/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.88%
1/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.9%
1/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.9%
1/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.81%
1/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Investigations
Alanine aminotransferase increased
|
0.81%
1/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.8%
1/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Investigations
Weight decreased
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.88%
1/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.9%
1/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Appendix cancer
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.9%
1/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.9%
1/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.8%
2/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.9%
1/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.88%
1/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.8%
1/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.88%
1/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.81%
1/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.81%
1/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.9%
1/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cystic lung disease
|
0.81%
1/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.81%
1/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Surgical and medical procedures
Abortion induced
|
0.81%
1/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
Other adverse events
| Measure |
Double-Blind: TAF 25 mg
n=123 participants at risk
Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
Double-Blind: TDF 300 mg
n=57 participants at risk
TDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks (per amendment 3.1).
|
Open-label TAF Extension Phase: TAF 25 mg to TAF 25 mg
n=113 participants at risk
After Week 144 in the Blinded Treatment Phase, participants were given the option to continue with OL TAF 25 mg for additional 240 weeks (Up to Week 384).
|
Open-label TAF Extension Phase: TDF 300 mg to TAF 25 mg
n=52 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).
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Hepatic steatosis
|
8.1%
10/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
5.3%
3/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
21.2%
24/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
34.6%
18/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Infections and infestations
Covid-19
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
39.8%
45/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
23.1%
12/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
6/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
5.3%
3/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
8.0%
9/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.9%
1/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
2/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
5.3%
3/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
General disorders
Pyrexia
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
7.0%
4/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.9%
1/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
1.6%
2/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
3.5%
2/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
7.1%
8/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
5.8%
3/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Hepatobiliary disorders
Hepatic cyst
|
4.1%
5/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.8%
1/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
7.7%
4/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Infections and infestations
Nasopharyngitis
|
32.5%
40/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
21.1%
12/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
9.7%
11/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
11.5%
6/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.88%
1/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
7.7%
4/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
5.8%
3/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Infections and infestations
Upper respiratory tract infection
|
22.0%
27/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
28.1%
16/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
17.7%
20/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
23.1%
12/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Infections and infestations
Urinary tract infection
|
6.5%
8/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
14.0%
8/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.8%
2/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
3.8%
2/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Investigations
Amylase increased
|
0.81%
1/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
5.3%
3/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
2.7%
3/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
3.5%
2/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.88%
1/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
5.8%
3/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Investigations
Blood parathyroid hormone increased
|
4.1%
5/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
7.0%
4/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
2.7%
3/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.9%
1/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Investigations
Creatinine renal clearance decreased
|
2.4%
3/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
5.3%
3/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.88%
1/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
5.8%
3/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.81%
1/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
3.5%
4/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
5.8%
3/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
4.9%
6/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
8.8%
10/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
3.8%
2/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.7%
7/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
3.5%
2/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.88%
1/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.9%
1/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
8.8%
5/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
5.3%
6/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
9.6%
5/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Nervous system disorders
Dizziness
|
4.9%
6/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
7.0%
4/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.8%
1/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
3.5%
4/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
5.8%
3/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
7.0%
4/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.88%
1/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.9%
1/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Renal and urinary disorders
Renal cyst
|
1.6%
2/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
6.2%
7/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
4/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
5.3%
3/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
3.5%
4/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
5.8%
3/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.7%
7/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
3.5%
2/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.8%
2/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.9%
1/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.81%
1/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
5.3%
3/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
3/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
5.3%
3/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
0.00%
0/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.9%
1/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
|
Vascular disorders
Hypertension
|
2.4%
3/123 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
1.8%
1/57 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
6.2%
7/113 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
13.5%
7/52 • All-Cause Mortality: Up to approximately 414 weeks; Adverse Events: Up to Week 384
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment they actually received during the double-blinded phase.
|
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