Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults (NCT NCT02607930)
NCT ID: NCT02607930
Last Updated: 2022-03-02
Results Overview
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
631 participants
Primary outcome timeframe
Week 48
Results posted on
2022-03-02
Participant Flow
Participants were enrolled at study centers in Europe, Dominican Republic, and North America. The first participant was screened on 13 November 2015. The last study visit occurred on 02 July 2021.
739 participants were screened.
Participant milestones
| Measure |
B/F/TAF
Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) (ABC/DTG/3TC) placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for 144 weeks, without regard to food.
|
B/F/TAF to B/F/TAF
After Week 144, participants continued to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
|
ABC/DTG/3TC to B/F/TAF
After Week 144, participants continued to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
|
|---|---|---|---|---|
|
Double-Blinded Treatment Phase
STARTED
|
316
|
315
|
0
|
0
|
|
Double-Blinded Treatment Phase
COMPLETED
|
262
|
262
|
0
|
0
|
|
Double-Blinded Treatment Phase
NOT COMPLETED
|
54
|
53
|
0
|
0
|
|
Open-Label B/F/TAF Extension Phase
STARTED
|
0
|
0
|
252
|
254
|
|
Open-Label B/F/TAF Extension Phase
COMPLETED
|
0
|
0
|
218
|
221
|
|
Open-Label B/F/TAF Extension Phase
NOT COMPLETED
|
0
|
0
|
34
|
33
|
Reasons for withdrawal
| Measure |
B/F/TAF
Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) (ABC/DTG/3TC) placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for 144 weeks, without regard to food.
|
B/F/TAF to B/F/TAF
After Week 144, participants continued to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
|
ABC/DTG/3TC to B/F/TAF
After Week 144, participants continued to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
|
|---|---|---|---|---|
|
Double-Blinded Treatment Phase
Lost to Follow-up
|
25
|
19
|
0
|
0
|
|
Double-Blinded Treatment Phase
Withdrew consent
|
14
|
18
|
0
|
0
|
|
Double-Blinded Treatment Phase
Investigator's discretion
|
6
|
3
|
0
|
0
|
|
Double-Blinded Treatment Phase
Non-compliance with study drug
|
3
|
5
|
0
|
0
|
|
Double-Blinded Treatment Phase
Protocol Violation
|
2
|
3
|
0
|
0
|
|
Double-Blinded Treatment Phase
Adverse Event
|
0
|
4
|
0
|
0
|
|
Double-Blinded Treatment Phase
Death
|
2
|
1
|
0
|
0
|
|
Double-Blinded Treatment Phase
Randomized but never treated
|
2
|
0
|
0
|
0
|
|
Open-Label B/F/TAF Extension Phase
Lost to Follow-up
|
0
|
0
|
15
|
10
|
|
Open-Label B/F/TAF Extension Phase
Withdrew consent
|
0
|
0
|
10
|
13
|
|
Open-Label B/F/TAF Extension Phase
Investigator's discretion
|
0
|
0
|
2
|
5
|
|
Open-Label B/F/TAF Extension Phase
Adverse Event
|
0
|
0
|
4
|
2
|
|
Open-Label B/F/TAF Extension Phase
Lack of Efficacy
|
0
|
0
|
1
|
1
|
|
Open-Label B/F/TAF Extension Phase
Protocol Violation
|
0
|
0
|
1
|
1
|
|
Open-Label B/F/TAF Extension Phase
Death
|
0
|
0
|
0
|
1
|
|
Open-Label B/F/TAF Extension Phase
Non-compliance with study drug
|
0
|
0
|
1
|
0
|
Baseline Characteristics
The Hip Dual-energy X-ray Absorptiometry (DXA) Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had non-missing values for baseline hip BMD.
Baseline characteristics by cohort
| Measure |
B/F/TAF
n=314 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food
Open-Label Extension Phase: After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.
|
ABC/DTG/3TC
n=315 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Open-Label Extension Phase: After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.
|
Total
n=629 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 10.9 • n=314 Participants
|
34 years
STANDARD_DEVIATION 10.8 • n=315 Participants
|
34 years
STANDARD_DEVIATION 10.8 • n=629 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=314 Participants
|
33 Participants
n=315 Participants
|
62 Participants
n=629 Participants
|
|
Sex: Female, Male
Male
|
285 Participants
n=314 Participants
|
282 Participants
n=315 Participants
|
567 Participants
n=629 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
2 Participants
n=314 Participants
|
4 Participants
n=315 Participants
|
6 Participants
n=629 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
6 Participants
n=314 Participants
|
10 Participants
n=315 Participants
|
16 Participants
n=629 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
114 Participants
n=314 Participants
|
112 Participants
n=315 Participants
|
226 Participants
n=629 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
1 Participants
n=314 Participants
|
2 Participants
n=315 Participants
|
3 Participants
n=629 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
180 Participants
n=314 Participants
|
179 Participants
n=315 Participants
|
359 Participants
n=629 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
9 Participants
n=314 Participants
|
8 Participants
n=315 Participants
|
17 Participants
n=629 Participants
|
|
Race/Ethnicity, Customized
Race · Not Permitted
|
2 Participants
n=314 Participants
|
0 Participants
n=315 Participants
|
2 Participants
n=629 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
72 Participants
n=314 Participants
|
65 Participants
n=315 Participants
|
137 Participants
n=629 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
240 Participants
n=314 Participants
|
249 Participants
n=315 Participants
|
489 Participants
n=629 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
2 Participants
n=314 Participants
|
1 Participants
n=315 Participants
|
3 Participants
n=629 Participants
|
|
Region of Enrollment
Canada
|
18 Participants
n=314 Participants
|
15 Participants
n=315 Participants
|
33 Participants
n=629 Participants
|
|
Region of Enrollment
Belgium
|
4 Participants
n=314 Participants
|
2 Participants
n=315 Participants
|
6 Participants
n=629 Participants
|
|
Region of Enrollment
United States
|
228 Participants
n=314 Participants
|
233 Participants
n=315 Participants
|
461 Participants
n=629 Participants
|
|
Region of Enrollment
Dominican Republic
|
2 Participants
n=314 Participants
|
1 Participants
n=315 Participants
|
3 Participants
n=629 Participants
|
|
Region of Enrollment
Italy
|
7 Participants
n=314 Participants
|
11 Participants
n=315 Participants
|
18 Participants
n=629 Participants
|
|
Region of Enrollment
United Kingdom
|
20 Participants
n=314 Participants
|
11 Participants
n=315 Participants
|
31 Participants
n=629 Participants
|
|
Region of Enrollment
France
|
11 Participants
n=314 Participants
|
10 Participants
n=315 Participants
|
21 Participants
n=629 Participants
|
|
Region of Enrollment
Germany
|
4 Participants
n=314 Participants
|
9 Participants
n=315 Participants
|
13 Participants
n=629 Participants
|
|
Region of Enrollment
Spain
|
20 Participants
n=314 Participants
|
23 Participants
n=315 Participants
|
43 Participants
n=629 Participants
|
|
HIV-1 RNA
|
4.41 log10 copies/mL
STANDARD_DEVIATION 0.647 • n=314 Participants
|
4.42 log10 copies/mL
STANDARD_DEVIATION 0.685 • n=315 Participants
|
4.42 log10 copies/mL
STANDARD_DEVIATION 0.665 • n=629 Participants
|
|
HIV-1 RNA Categories
≤ 100,000 copies/mL
|
261 Participants
n=314 Participants
|
265 Participants
n=315 Participants
|
526 Participants
n=629 Participants
|
|
HIV-1 RNA Categories
> 100,000 ≤ 400,000 copies/mL
|
45 Participants
n=314 Participants
|
38 Participants
n=315 Participants
|
83 Participants
n=629 Participants
|
|
HIV-1 RNA Categories
> 400,000 copies/mL
|
8 Participants
n=314 Participants
|
12 Participants
n=315 Participants
|
20 Participants
n=629 Participants
|
|
CD4 Cell Count
|
453 Cells/µL
STANDARD_DEVIATION 220.8 • n=314 Participants
|
476 Cells/µL
STANDARD_DEVIATION 231.4 • n=315 Participants
|
464 Cells/µL
STANDARD_DEVIATION 226.3 • n=629 Participants
|
|
CD4 Cell Count Categories
< 50 Cells/µL
|
7 Participants
n=314 Participants
|
10 Participants
n=315 Participants
|
17 Participants
n=629 Participants
|
|
CD4 Cell Count Categories
≥ 50 to < 200 Cells/µL
|
29 Participants
n=314 Participants
|
22 Participants
n=315 Participants
|
51 Participants
n=629 Participants
|
|
CD4 Cell Count Categories
≥ 200 to < 350 Cells/µL
|
69 Participants
n=314 Participants
|
58 Participants
n=315 Participants
|
127 Participants
n=629 Participants
|
|
CD4 Cell Count Categories
≥ 350 to < 500 Cells/µL
|
87 Participants
n=314 Participants
|
91 Participants
n=315 Participants
|
178 Participants
n=629 Participants
|
|
CD4 Cell Count Categories
≥ 500 Cells/µL
|
122 Participants
n=314 Participants
|
134 Participants
n=315 Participants
|
256 Participants
n=629 Participants
|
|
Hip Bone Mineral Density (BMD)
|
1.048 g/cm^2
STANDARD_DEVIATION 0.1572 • n=300 Participants • The Hip Dual-energy X-ray Absorptiometry (DXA) Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had non-missing values for baseline hip BMD.
|
1.057 g/cm^2
STANDARD_DEVIATION 0.1520 • n=297 Participants • The Hip Dual-energy X-ray Absorptiometry (DXA) Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had non-missing values for baseline hip BMD.
|
1.052 g/cm^2
STANDARD_DEVIATION 0.1546 • n=597 Participants • The Hip Dual-energy X-ray Absorptiometry (DXA) Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had non-missing values for baseline hip BMD.
|
|
Spine BMD
|
1.139 g/cm^2
STANDARD_DEVIATION 0.1847 • n=304 Participants • The Spine DXA Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing values for baseline spine BMD.
|
1.142 g/cm^2
STANDARD_DEVIATION 0.1713 • n=299 Participants • The Spine DXA Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing values for baseline spine BMD.
|
1.140 g/cm^2
STANDARD_DEVIATION 0.1780 • n=603 Participants • The Spine DXA Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing values for baseline spine BMD.
|
PRIMARY outcome
Timeframe: Week 48Population: Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
B/F/TAF
n=314 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=315 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
|
92.4 percentage of participants
|
93.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 96Population: Participants in the Full Analysis Set were analyzed.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
B/F/TAF
n=314 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=315 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
|
87.9 percentage of participants
|
89.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 144Population: Participants in the Full Analysis Set were analyzed.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
B/F/TAF
n=314 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=315 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
|
81.5 percentage of participants
|
84.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed.
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
B/F/TAF
n=314 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=315 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
|
87.6 percentage of participants
|
87.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 96Population: Participants in the Full Analysis Set were analyzed.
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
B/F/TAF
n=314 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=315 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
|
83.4 percentage of participants
|
84.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 144Population: Participants in the Full Analysis Set were analyzed.
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
B/F/TAF
n=314 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=315 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
|
78.0 percentage of participants
|
82.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
B/F/TAF
n=295 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=302 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Change From Baseline in log10 HIV-1 RNA at Week 48
|
-3.11 log10 copies/mL
Standard Deviation 0.641
|
-3.07 log10 copies/mL
Standard Deviation 0.738
|
SECONDARY outcome
Timeframe: Baseline, Week 96Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
B/F/TAF
n=279 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=288 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Change From Baseline in log10 HIV-1 RNA at Week 96
|
-3.09 log10 copies/mL
Standard Deviation 0.643
|
-3.10 log10 copies/mL
Standard Deviation 0.705
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
B/F/TAF
n=260 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=269 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Change From Baseline in log10 HIV-1 RNA at Week 144
|
-3.11 log10 copies/mL
Standard Deviation 0.639
|
-3.10 log10 copies/mL
Standard Deviation 0.681
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
B/F/TAF
n=294 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=300 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 48
|
235 cells/µL
Standard Deviation 185.8
|
228 cells/µL
Standard Deviation 188.7
|
SECONDARY outcome
Timeframe: Baseline, Week 96Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
B/F/TAF
n=276 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=286 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 96
|
287 cells/µL
Standard Deviation 206.9
|
288 cells/µL
Standard Deviation 246.8
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
B/F/TAF
n=255 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=260 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 144
|
299 cells/µL
Standard Deviation 224.9
|
317 cells/µL
Standard Deviation 219.5
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants in the Hip DXA Analysis Set with available data were analyzed.
Outcome measures
| Measure |
B/F/TAF
n=278 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=281 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Percentage Change From Baseline in Hip BMD at Week 48
|
-0.802 percentage change
Standard Deviation 2.3280
|
-1.148 percentage change
Standard Deviation 2.5126
|
SECONDARY outcome
Timeframe: Baseline, Week 96Population: Participants in the Hip DXA Analysis Set with available data were analyzed.
Outcome measures
| Measure |
B/F/TAF
n=250 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=257 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Percentage Change From Baseline in Hip BMD at Week 96
|
-1.128 percentage change
Standard Deviation 2.7702
|
-1.262 percentage change
Standard Deviation 2.8524
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: Participants in the Hip DXA Analysis Set with available data were analyzed.
Outcome measures
| Measure |
B/F/TAF
n=236 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=240 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Percentage Change From Baseline in Hip BMD at Week 144
|
-1.020 percentage change
Standard Deviation 3.7638
|
-1.291 percentage change
Standard Deviation 3.1140
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants in the Spine DXA Analysis Set with available data were analyzed.
Outcome measures
| Measure |
B/F/TAF
n=284 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=285 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Percentage Change From Baseline in Spine BMD at Week 48
|
-0.772 percentage change
Standard Deviation 3.2228
|
-0.552 percentage change
Standard Deviation 3.0956
|
SECONDARY outcome
Timeframe: Baseline, Week 96Population: Participants in the Spine DXA Analysis Set with available data were analyzed.
Outcome measures
| Measure |
B/F/TAF
n=256 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=258 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Percentage Change From Baseline in Spine BMD at Week 96
|
-0.705 percentage change
Standard Deviation 3.8721
|
-0.219 percentage change
Standard Deviation 3.5159
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: Participants in the Spine DXA Analysis Set with available data were analyzed.
Outcome measures
| Measure |
B/F/TAF
n=243 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=244 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Percentage Change From Baseline in Spine BMD at Week 144
|
-0.371 percentage change
Standard Deviation 4.4369
|
0.035 percentage change
Standard Deviation 3.5182
|
SECONDARY outcome
Timeframe: Baseline, open-label Week 48Population: Participants in All B/F/TAF Analysis Set (who were randomized into the randomized phase of the study and received at least 1 dose of the B/F/TAF in the randomized phase or at least 1 dose of the B/F/TAF in the open label extension phase) with available data were analyzed. For the B/F/TAF group, Week 48 open-label time point refers to Week 192; for Missing = Excluded analysis, it included the available participants at that time point from the Randomized Phase.
The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit.
Outcome measures
| Measure |
B/F/TAF
n=237 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=212 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm
|
99.2 percentage of participants
Interval 97.0 to 99.9
|
100 percentage of participants
Interval 98.3 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, open-label Week 48Population: Participants in the All B/F/TAF Analysis Set were analyzed. For the B/F/TAF group, Week 48 open-label time point refers to Week 192; for Missing = Failure analysis, it included all participants from the Randomized Phase.
The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.
Outcome measures
| Measure |
B/F/TAF
n=314 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=254 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm
|
74.8 percentage of participants
Interval 69.7 to 79.5
|
83.5 percentage of participants
Interval 78.3 to 87.8
|
SECONDARY outcome
Timeframe: Baseline, open-label Week 96Population: Participants in the All B/F/TAF Analysis Set with available data were analyzed. For the B/F/TAF group, Week 96 open-label time point refers to Week 240; for Missing = Excluded analysis, it included the available participants at that time point from the Randomized Phase.
The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit.
Outcome measures
| Measure |
B/F/TAF
n=213 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=218 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm
|
97.7 percentage of participants
Interval 94.6 to 99.2
|
99.5 percentage of participants
Interval 97.5 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, open-label Week 96Population: Participants in the All B/F/TAF Analysis Set were analyzed. For the B/F/TAF group, Week 96 open-label time point refers to Week 240; for Missing = Failure analysis, it included all participants from the Randomized Phase.
The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.
Outcome measures
| Measure |
B/F/TAF
n=314 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=254 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm
|
66.2 percentage of participants
Interval 60.7 to 71.5
|
85.4 percentage of participants
Interval 80.5 to 89.5
|
SECONDARY outcome
Timeframe: Baseline, open-label Week 48Population: Participants in the All B/F/TAF Analysis Set with available data were analyzed. For the B/F/TAF group, Week 48 open-label time point refers to Week 192; for Change from Baseline in CD4 Cell Count analysis, it included the available participants at that time point from the Randomized Phase.
Outcome measures
| Measure |
B/F/TAF
n=234 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=212 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 48 Open-Label
|
330 cells/µL
Standard Deviation 242.8
|
-4 cells/µL
Standard Deviation 202.0
|
SECONDARY outcome
Timeframe: Baseline, open-label Week 96Population: Participants in the All B/F/TAF Analysis Set with available data were analyzed. For the B/F/TAF group, Week 96 open-label time point refers to Week 240; for Change from Baseline in CD4 Cell Count analysis, it included the available participants at that time point from the Randomized Phase.
Outcome measures
| Measure |
B/F/TAF
n=205 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=204 Participants
Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 96 Open-Label
|
339 cell/µL
Standard Deviation 237.8
|
-15 cell/µL
Standard Deviation 188.1
|
Adverse Events
B/F/TAF
Serious events: 44 serious events
Other events: 262 other events
Deaths: 2 deaths
ABC/DTG/3TC
Serious events: 54 serious events
Other events: 276 other events
Deaths: 1 deaths
B/F/TAF to B/F/TAF
Serious events: 19 serious events
Other events: 152 other events
Deaths: 2 deaths
ABC/DTG/3TC to B/F/TAF
Serious events: 19 serious events
Other events: 153 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
B/F/TAF
n=314 participants at risk
B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=315 participants at risk
ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
B/F/TAF to B/F/TAF
n=252 participants at risk
After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
|
ABC/DTG/3TC to B/F/TAF
n=254 participants at risk
After Week 144, participants continued to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.64%
2/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Ear and labyrinth disorders
Middle ear adhesions
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Endocrine disorders
Goitre
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Eye disorders
Blindness transient
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Haematemesis
|
0.64%
2/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.63%
2/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
General disorders
Chest discomfort
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
General disorders
Chest pain
|
0.64%
2/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.63%
2/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
General disorders
Death
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
General disorders
Pyrexia
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Abdominal wall abscess
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Abscess limb
|
0.64%
2/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.63%
2/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Appendicitis
|
0.96%
3/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.63%
2/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Appendicitis perforated
|
0.64%
2/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Cellulitis
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.79%
2/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Complicated appendicitis
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Covid-19
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.79%
2/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Fungaemia
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.63%
2/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Gonococcal infection
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Gonorrhoea
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.63%
2/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Injection site cellulitis
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Localised infection
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Mastoiditis
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Meningitis cryptococcal
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Neurosyphilis
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.63%
2/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Orchitis
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Pharyngeal abscess
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Pneumonia
|
0.64%
2/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.63%
2/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Septic shock
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Soft tissue infection
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Wound infection
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.64%
2/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.95%
3/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.63%
2/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Investigations
Psychiatric evaluation
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Investigations
White blood cell count increased
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic large-cell lymphoma
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
High-grade B-cell lymphoma
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.63%
2/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Nervous system disorders
Seizure
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Psychiatric disorders
Anxiety
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Psychiatric disorders
Borderline personality disorder
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Psychiatric disorders
Delirium tremens
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.63%
2/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Psychiatric disorders
Hallucination, tactile
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Psychiatric disorders
Intentional self-injury
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Psychiatric disorders
Major depression
|
0.96%
3/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Psychiatric disorders
Mental disorder
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Psychiatric disorders
Psychotic disorder
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.96%
3/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.95%
3/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Psychiatric disorders
Suicide attempt
|
0.64%
2/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.79%
2/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Reproductive system and breast disorders
Endometrial thickening
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Reproductive system and breast disorders
Penile necrosis
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Reproductive system and breast disorders
Testicular mass
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.39%
1/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Social circumstances
Alcohol use
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.40%
1/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.32%
1/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.32%
1/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
Other adverse events
| Measure |
B/F/TAF
n=314 participants at risk
B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food.
|
ABC/DTG/3TC
n=315 participants at risk
ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
B/F/TAF to B/F/TAF
n=252 participants at risk
After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
|
ABC/DTG/3TC to B/F/TAF
n=254 participants at risk
After Week 144, participants continued to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
18/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
7.3%
23/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.0%
5/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.4%
6/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Constipation
|
4.8%
15/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
5.4%
17/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.79%
2/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.4%
6/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.2%
54/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
18.1%
57/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.4%
6/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
5.1%
13/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Nausea
|
12.7%
40/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
24.4%
77/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.2%
8/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.8%
7/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
18/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
7.6%
24/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
1.2%
3/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.8%
7/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
General disorders
Fatigue
|
11.1%
35/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
13.0%
41/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.8%
7/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
4.3%
11/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
General disorders
Pyrexia
|
4.8%
15/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
6.0%
19/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.2%
8/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.1%
8/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Immune system disorders
Seasonal allergy
|
2.2%
7/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
5.1%
16/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
1.2%
3/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.0%
5/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Anal chlamydia infection
|
5.1%
16/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
9.2%
29/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.4%
6/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
4.3%
11/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Bronchitis
|
6.4%
20/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
9.5%
30/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
1.2%
3/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.79%
2/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Chlamydial infection
|
7.3%
23/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
4.1%
13/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.2%
8/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.1%
8/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Covid-19
|
0.00%
0/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
7.9%
20/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
9.1%
23/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Gastroenteritis
|
5.4%
17/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
6.7%
21/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.4%
6/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.1%
8/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Gonorrhoea
|
7.0%
22/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
6.7%
21/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.0%
5/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.0%
5/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Influenza
|
7.0%
22/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
5.1%
16/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
1.6%
4/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.5%
9/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Nasopharyngitis
|
13.1%
41/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
16.5%
52/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
7.1%
18/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
5.5%
14/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Pharyngitis
|
5.4%
17/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
7.3%
23/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.4%
6/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.0%
5/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Proctitis gonococcal
|
5.4%
17/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
6.7%
21/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.6%
9/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
5.1%
13/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Sinusitis
|
4.8%
15/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
7.3%
23/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
1.2%
3/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
1.6%
4/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Syphilis
|
13.7%
43/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
16.2%
51/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
8.7%
22/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
8.7%
22/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.6%
46/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
19.4%
61/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
6.3%
16/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
7.5%
19/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.5%
36/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
13.0%
41/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
5.2%
13/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
4.7%
12/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
35/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
13.7%
43/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
6.0%
15/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
5.9%
15/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
18/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
4.1%
13/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.6%
9/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
4.7%
12/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
3.8%
12/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
6.0%
19/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.4%
6/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
1.2%
3/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Nervous system disorders
Dizziness
|
3.2%
10/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
6.0%
19/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.79%
2/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.79%
2/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Nervous system disorders
Headache
|
14.0%
44/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
17.8%
56/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.2%
8/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.5%
9/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Psychiatric disorders
Anxiety
|
9.9%
31/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
6.7%
21/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
4.4%
11/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
4.7%
12/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Psychiatric disorders
Depression
|
6.1%
19/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
8.6%
27/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
1.6%
4/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
4.7%
12/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Psychiatric disorders
Insomnia
|
8.6%
27/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
11.1%
35/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.2%
8/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.0%
5/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.8%
34/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
7.0%
22/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
5.2%
13/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.5%
9/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.0%
22/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
11.1%
35/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
5.2%
13/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.4%
6/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.6%
30/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
10.2%
32/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
4.0%
10/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.4%
6/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
|
Vascular disorders
Hypertension
|
7.6%
24/314 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
5.1%
16/315 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.2%
8/252 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.5%
9/254 • Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
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