Trial Outcomes & Findings for Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant (NCT NCT02862548)
NCT ID: NCT02862548
Last Updated: 2022-06-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2022-06-08
Participant Flow
Participants were enrolled at a study site in New Zealand. The first participant was screened on 16 September 2016. The last study visit occurred on 05 May 2021.
57 participants were screened.
Participant milestones
| Measure |
TAF 25 mg
Randomized Phase: Tenofovir alafenamide (TAF) 25 mg tablet orally once daily for 48 weeks
Open-Label Extension (OLE) Phase: TAF 25 mg tablet orally once daily for additional 144 weeks
|
TDF-Containing Regimens
Randomized Phase: Tenofovir disoproxil fumarate (TDF) alone or in combination with other approved antivirals per local practice for 48 weeks
OLE Phase: TAF 25 mg tablet orally once daily for additional 144 weeks
|
|---|---|---|
|
Randomized Phase (Up to Week 48)
STARTED
|
26
|
25
|
|
Randomized Phase (Up to Week 48)
COMPLETED
|
26
|
24
|
|
Randomized Phase (Up to Week 48)
NOT COMPLETED
|
0
|
1
|
|
OLE Phase (Week 49 to Week 192)
STARTED
|
26
|
24
|
|
OLE Phase (Week 49 to Week 192)
COMPLETED
|
23
|
23
|
|
OLE Phase (Week 49 to Week 192)
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
TAF 25 mg
Randomized Phase: Tenofovir alafenamide (TAF) 25 mg tablet orally once daily for 48 weeks
Open-Label Extension (OLE) Phase: TAF 25 mg tablet orally once daily for additional 144 weeks
|
TDF-Containing Regimens
Randomized Phase: Tenofovir disoproxil fumarate (TDF) alone or in combination with other approved antivirals per local practice for 48 weeks
OLE Phase: TAF 25 mg tablet orally once daily for additional 144 weeks
|
|---|---|---|
|
Randomized Phase (Up to Week 48)
Death
|
0
|
1
|
|
OLE Phase (Week 49 to Week 192)
Death
|
2
|
0
|
|
OLE Phase (Week 49 to Week 192)
Adverse Event
|
1
|
0
|
|
OLE Phase (Week 49 to Week 192)
Withdrew Consent
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant
Baseline characteristics by cohort
| Measure |
TAF 25 mg
n=26 Participants
Randomized Phase: TAF 25 mg tablet orally once daily for 48 weeks
OLE Phase: TAF 25 mg tablet orally once daily for additional 144 weeks
|
TDF-Containing Regimens
n=25 Participants
Randomized Phase: TDF alone or in combination with other approved antivirals per local practice for 48 weeks
OLE Phase: TAF 25 mg tablet orally once daily for additional 144 weeks
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
62 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
60 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 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
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 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
Race · Asian
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
HBV Deoxy Ribonucleic Acid (DNA)
|
19.0 International unit per mL (IU/mL)
STANDARD_DEVIATION 0.00 • n=5 Participants
|
19.0 International unit per mL (IU/mL)
STANDARD_DEVIATION 0.00 • n=7 Participants
|
19.0 International unit per mL (IU/mL)
STANDARD_DEVIATION 0.00 • n=5 Participants
|
|
eGFR by CKD-EPI Creatinine
|
52.3 mL/minute/1.73 square meter(m^2)
STANDARD_DEVIATION 12.31 • n=5 Participants
|
52.4 mL/minute/1.73 square meter(m^2)
STANDARD_DEVIATION 12.74 • n=7 Participants
|
52.4 mL/minute/1.73 square meter(m^2)
STANDARD_DEVIATION 12.40 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
TAF 25 mg
n=26 Participants
Randomized Phase: TAF 25 mg tablet orally once daily for 48 weeks
|
TDF-Containing Regimens
n=25 Participants
Randomized Phase: TDF alone or in combination with other approved antivirals per local practice for 48 weeks
|
|---|---|---|
|
Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) at Week 24 Using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation
|
2.13 mL/min/1.73 m^2
Standard Deviation 6.011
|
1.87 mL/min/1.73 m^2
Standard Deviation 6.553
|
PRIMARY outcome
Timeframe: Week 24Population: Full Analysis Set included all randomized participants who have received at least 1 dose of study drug. The missing = failure approach was used.
Outcome measures
| Measure |
TAF 25 mg
n=26 Participants
Randomized Phase: TAF 25 mg tablet orally once daily for 48 weeks
|
TDF-Containing Regimens
n=25 Participants
Randomized Phase: TDF alone or in combination with other approved antivirals per local practice for 48 weeks
|
|---|---|---|
|
Percentage of Participants With HBV DNA < 20 IU/mL at Week 24
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Hip dual energy x-ray absorptiometry (DXA) Analysis Set included participants who were randomized and had received at least 1 dose of study drug, and had nonmissing baseline hip BMD values.
Outcome measures
| Measure |
TAF 25 mg
n=26 Participants
Randomized Phase: TAF 25 mg tablet orally once daily for 48 weeks
|
TDF-Containing Regimens
n=25 Participants
Randomized Phase: TDF alone or in combination with other approved antivirals per local practice for 48 weeks
|
|---|---|---|
|
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24
|
0.478 percent change
Standard Deviation 1.6342
|
0.452 percent change
Standard Deviation 2.1380
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants in the Hip DXA Analysis Set with available data were analyzed.
Outcome measures
| Measure |
TAF 25 mg
n=26 Participants
Randomized Phase: TAF 25 mg tablet orally once daily for 48 weeks
|
TDF-Containing Regimens
n=23 Participants
Randomized Phase: TDF alone or in combination with other approved antivirals per local practice for 48 weeks
|
|---|---|---|
|
Percent Change From Baseline in Hip BMD at Week 48
|
1.253 percent change
Standard Deviation 1.9774
|
-0.413 percent change
Standard Deviation 2.6361
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Spine DXA Analysis Set included participants who were randomized and had received at least 1 dose of study drug, and had nonmissing baseline spine BMD values.
Outcome measures
| Measure |
TAF 25 mg
n=26 Participants
Randomized Phase: TAF 25 mg tablet orally once daily for 48 weeks
|
TDF-Containing Regimens
n=24 Participants
Randomized Phase: TDF alone or in combination with other approved antivirals per local practice for 48 weeks
|
|---|---|---|
|
Percent Change From Baseline in Spine BMD at Week 24
|
0.799 percent change
Standard Deviation 2.5563
|
-0.188 percent change
Standard Deviation 2.5890
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants in the Spine DXA Analysis Set with available data were analyzed.
Outcome measures
| Measure |
TAF 25 mg
n=26 Participants
Randomized Phase: TAF 25 mg tablet orally once daily for 48 weeks
|
TDF-Containing Regimens
n=21 Participants
Randomized Phase: TDF alone or in combination with other approved antivirals per local practice for 48 weeks
|
|---|---|---|
|
Percent Change From Baseline in Spine BMD at Week 48
|
1.454 percent change
Standard Deviation 4.5405
|
-1.082 percent change
Standard Deviation 3.0031
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants in the Safety Analysis Set were analyzed.
Outcome measures
| Measure |
TAF 25 mg
n=26 Participants
Randomized Phase: TAF 25 mg tablet orally once daily for 48 weeks
|
TDF-Containing Regimens
n=25 Participants
Randomized Phase: TDF alone or in combination with other approved antivirals per local practice for 48 weeks
|
|---|---|---|
|
Change From Baseline in Serum Creatinine at Week 24
|
-0.043 mg/dL
Standard Deviation 0.1434
|
-0.040 mg/dL
Standard Deviation 0.1623
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants in the Safety Analysis Set with available data were analyzed.
Outcome measures
| Measure |
TAF 25 mg
n=26 Participants
Randomized Phase: TAF 25 mg tablet orally once daily for 48 weeks
|
TDF-Containing Regimens
n=22 Participants
Randomized Phase: TDF alone or in combination with other approved antivirals per local practice for 48 weeks
|
|---|---|---|
|
Change From Baseline in Serum Creatinine at Week 48
|
-0.052 mg/dL
Standard Deviation 0.2233
|
-0.058 mg/dL
Standard Deviation 0.2158
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants in the Safety Analysis Set with available data were analyzed.
Outcome measures
| Measure |
TAF 25 mg
n=26 Participants
Randomized Phase: TAF 25 mg tablet orally once daily for 48 weeks
|
TDF-Containing Regimens
n=22 Participants
Randomized Phase: TDF alone or in combination with other approved antivirals per local practice for 48 weeks
|
|---|---|---|
|
Change From Baseline in Serum eGFR_CKD-EPI at Week 48
|
3.01 mL/min/1.73 m^2
Standard Deviation 9.385
|
2.09 mL/min/1.73 m^2
Standard Deviation 9.209
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed. The missing = failure approach was used.
Outcome measures
| Measure |
TAF 25 mg
n=26 Participants
Randomized Phase: TAF 25 mg tablet orally once daily for 48 weeks
|
TDF-Containing Regimens
n=25 Participants
Randomized Phase: TDF alone or in combination with other approved antivirals per local practice for 48 weeks
|
|---|---|---|
|
Percentage of Participants With HBV DNA < 20 IU/mL at Week 48
|
100.0 percentage of participants
|
88.0 percentage of participants
|
Adverse Events
Randomized Phase: TAF 25 mg
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Randomized Phase: TDF-Containing Regimens
Serious events: 7 serious events
Other events: 17 other events
Deaths: 1 deaths
OLE Phase: TAF 25 mg From TAF
Serious events: 8 serious events
Other events: 22 other events
Deaths: 2 deaths
OLE Phase: TAF 25 mg From TDF
Serious events: 8 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Randomized Phase: TAF 25 mg
n=26 participants at risk
TAF 25 mg tablet orally once daily for 48 weeks
|
Randomized Phase: TDF-Containing Regimens
n=25 participants at risk
TDF alone or in combination with other approved antivirals per local practice for 48 weeks
|
OLE Phase: TAF 25 mg From TAF
n=26 participants at risk
Participants who received TAF 25 mg in randomized phase received TAF 25 mg tablet orally once daily for additional 144 weeks in OLE phase.
|
OLE Phase: TAF 25 mg From TDF
n=24 participants at risk
Participants who received TDF alone o in combination with approved antivirals per local practice in randomized phase received TAF 25 mg tablet orally once daily for additional 144 weeks in OLE phase.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Biliary tract disorder
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.0%
2/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic infarction
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Transplant rejection
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
1/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
1/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Disseminated cryptococcosis
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
1/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Disseminated varicella zoster virus infection
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Osteomyelitis fungal
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
1/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
1/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
1/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Complications of transplanted liver
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Liver function test abnormal
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
1/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
1/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
16.7%
4/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Randomized Phase: TAF 25 mg
n=26 participants at risk
TAF 25 mg tablet orally once daily for 48 weeks
|
Randomized Phase: TDF-Containing Regimens
n=25 participants at risk
TDF alone or in combination with other approved antivirals per local practice for 48 weeks
|
OLE Phase: TAF 25 mg From TAF
n=26 participants at risk
Participants who received TAF 25 mg in randomized phase received TAF 25 mg tablet orally once daily for additional 144 weeks in OLE phase.
|
OLE Phase: TAF 25 mg From TDF
n=24 participants at risk
Participants who received TDF alone o in combination with approved antivirals per local practice in randomized phase received TAF 25 mg tablet orally once daily for additional 144 weeks in OLE phase.
|
|---|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.0%
2/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.5%
3/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
1/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
1/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
1/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.0%
2/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
3/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
20.0%
5/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
11.5%
3/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
12.0%
3/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Bone density decreased
|
11.5%
3/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
1/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
12.5%
3/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.0%
2/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
19.2%
5/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
4/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
1/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
15.4%
4/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
15.4%
4/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.0%
2/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lethargy
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.0%
2/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
12.5%
3/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
4/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.0%
2/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
19.2%
5/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
12.5%
3/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
3.8%
1/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.0%
2/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.2%
1/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
2/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
1/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
11.5%
3/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
4.0%
1/25 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/26 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
|
8.3%
2/24 • All-Cause Mortality: Randomization up to last follow up visit (maximum 236.7 weeks); Adverse Events: First dose date up to last dose date plus 30 days (maximum 225.9 weeks)
All-Cause Mortality: Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: Safety Analysis Set included all randomized participants who 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