Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults (NCT NCT02607956)
NCT ID: NCT02607956
Last Updated: 2022-03-07
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
657 participants
Primary outcome timeframe
Week 48
Results posted on
2022-03-07
Participant Flow
Participants were enrolled at centers in Australia, Europe, North America, and the Dominican Republic. The first participant was screened on 11 November 2015. The last study visit occurred on 05 July 2021.
742 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) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food.
|
DTG + F/TAF
DTG (50 mg) + F/TAF (200/25 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
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 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.
|
DTG + F/TAF to B/F/TAF
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 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.
|
|---|---|---|---|---|
|
Double-Blinded Phase
STARTED
|
327
|
330
|
0
|
0
|
|
Double-Blinded Phase
COMPLETED
|
266
|
277
|
0
|
0
|
|
Double-Blinded Phase
NOT COMPLETED
|
61
|
53
|
0
|
0
|
|
Open-Label Extension Phase
STARTED
|
0
|
0
|
254
|
265
|
|
Open-Label Extension Phase
COMPLETED
|
0
|
0
|
225
|
235
|
|
Open-Label Extension Phase
NOT COMPLETED
|
0
|
0
|
29
|
30
|
Reasons for withdrawal
| Measure |
B/F/TAF
Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food.
|
DTG + F/TAF
DTG (50 mg) + F/TAF (200/25 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
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 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.
|
DTG + F/TAF to B/F/TAF
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 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.
|
|---|---|---|---|---|
|
Double-Blinded Phase
Withdrew Consent
|
17
|
19
|
0
|
0
|
|
Double-Blinded Phase
Lost to Follow-up
|
19
|
16
|
0
|
0
|
|
Double-Blinded Phase
Randomized but never treated
|
7
|
5
|
0
|
0
|
|
Double-Blinded Phase
Investigator's Discretion
|
7
|
2
|
0
|
0
|
|
Double-Blinded Phase
Death
|
4
|
4
|
0
|
0
|
|
Double-Blinded Phase
Adverse Event
|
4
|
3
|
0
|
0
|
|
Double-Blinded Phase
Protocol Violation
|
3
|
1
|
0
|
0
|
|
Double-Blinded Phase
Non-Compliance with Study Drug
|
0
|
3
|
0
|
0
|
|
Open-Label Extension Phase
Withdrew Consent
|
0
|
0
|
10
|
16
|
|
Open-Label Extension Phase
Lost to Follow-up
|
0
|
0
|
14
|
6
|
|
Open-Label Extension Phase
Death
|
0
|
0
|
1
|
3
|
|
Open-Label Extension Phase
Investigator's Discretion
|
0
|
0
|
2
|
2
|
|
Open-Label Extension Phase
Non Compliance with Study Drug
|
0
|
0
|
2
|
0
|
|
Open-Label Extension Phase
Protocol Violation
|
0
|
0
|
0
|
2
|
|
Open-Label Extension Phase
Pregnancy
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Baseline characteristics by cohort
| Measure |
B/F/TAF
n=320 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food
Open-Label Extension Phase: 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.
|
DTG + F/TAF
n=325 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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 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.
|
Total
n=645 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
83 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
237 Participants
n=5 Participants
|
244 Participants
n=7 Participants
|
481 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
193 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
386 Participants
n=5 Participants
|
|
Region of Enrollment
Dominican Republic
|
27 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
20 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
HIV-1 RNA
|
4.39 log10 copies/mL
STANDARD_DEVIATION 0.730 • n=5 Participants
|
4.42 log10 copies/mL
STANDARD_DEVIATION 0.669 • n=7 Participants
|
4.41 log10 copies/mL
STANDARD_DEVIATION 0.700 • n=5 Participants
|
|
HIV-1 RNA Categories
≤ 100,000 copies/mL
|
254 Participants
n=5 Participants
|
271 Participants
n=7 Participants
|
525 Participants
n=5 Participants
|
|
HIV-1 RNA Categories
> 100,000 ≤ 400,000 copies/mL
|
54 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
HIV-1 RNA Categories
> 400,000 copies/mL
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
CD4 Cell Count
|
457 Cells/µL
STANDARD_DEVIATION 255.3 • n=5 Participants
|
454 Cells/µL
STANDARD_DEVIATION 231.5 • n=7 Participants
|
456 Cells/µL
STANDARD_DEVIATION 243.4 • n=5 Participants
|
|
CD4 Cell Count Categories
< 50 cells/μL
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
CD4 Cell Count Categories
≥ 50 to < 200 cells/μL
|
29 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
CD4 Cell Count Categories
≥ 200 to < 350 cells/μL
|
67 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
CD4 Cell Count Categories
≥ 350 to < 500 cells/μL
|
91 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
CD4 Cell Count Categories
≥ 500 cells/μL
|
118 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
37 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
37 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
280 Participants
n=5 Participants
|
288 Participants
n=7 Participants
|
568 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
97 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
183 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
378 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
31 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
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=320 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=325 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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
|
89.4 percentage of participants
|
92.9 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=320 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=325 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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
|
84.1 percentage of participants
|
86.5 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=320 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=325 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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
|
81.9 percentage of participants
|
84.0 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=320 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=325 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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
|
82.2 percentage of participants
|
87.1 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=320 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=325 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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
|
77.5 percentage of participants
|
80.3 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=320 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=325 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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
|
77.5 percentage of participants
|
79.1 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=294 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=308 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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
|
-3.07 log10 copies/mL
Standard Deviation 0.719
|
-3.12 log10 copies/mL
Standard Deviation 0.672
|
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 + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=291 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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
|
-3.08 log10 copies/mL
Standard Deviation 0.703
|
-3.10 log10 copies/mL
Standard Deviation 0.713
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
B/F/TAF
n=270 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=280 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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
|
-3.06 log10 copies/mL
Standard Deviation 0.731
|
-3.11 log10 copies/mL
Standard Deviation 0.672
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
B/F/TAF
n=290 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=304 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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
|
180 cells/μL
Standard Deviation 166.2
|
201 cells/μL
Standard Deviation 165.9
|
SECONDARY outcome
Timeframe: Baseline, Week 96Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
B/F/TAF
n=269 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=285 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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
|
237 cells/μL
Standard Deviation 204.2
|
281 cells/μL
Standard Deviation 209.3
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
B/F/TAF
n=262 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=277 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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
|
278 cells/μL
Standard Deviation 236.6
|
289 cells/μL
Standard Deviation 218.5
|
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 for the all B/F/TAF analysis. 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 nonmissing HIV-1 RNA value at that visit.
Outcome measures
| Measure |
B/F/TAF
n=243 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=225 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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 97.1 to 99.9
|
99.6 percentage of participants
Interval 97.5 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 for the all B/F/TAF analysis. 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=320 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=265 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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
|
75.3 percentage of participants
Interval 70.2 to 79.9
|
84.5 percentage of participants
Interval 79.6 to 88.7
|
SECONDARY outcome
Timeframe: Baseline, open-label Week 96Population: Participants in 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 for the all B/F/TAF analysis. 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 nonmissing HIV-1 RNA value at that visit.
Outcome measures
| Measure |
B/F/TAF
n=219 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=234 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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
|
99.5 percentage of participants
Interval 97.5 to 100.0
|
99.1 percentage of participants
Interval 96.9 to 99.9
|
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 for the all B/F/TAF analysis. 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=320 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=265 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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
|
68.1 percentage of participants
Interval 62.7 to 73.2
|
87.5 percentage of participants
Interval 83.0 to 91.3
|
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=241 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=223 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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
|
304 cells/μL
Standard Deviation 249.2
|
9 cells/μL
Standard Deviation 198.0
|
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=210 Participants
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=225 Participants
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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
|
336 cells/µL
Standard Deviation 235.1
|
-10 cells/µL
Standard Deviation 181.1
|
Adverse Events
B/F/TAF
Serious events: 64 serious events
Other events: 250 other events
Deaths: 4 deaths
DTG + F/TAF
Serious events: 46 serious events
Other events: 262 other events
Deaths: 4 deaths
B/F/TAF to B/F/TAF
Serious events: 20 serious events
Other events: 165 other events
Deaths: 1 deaths
DTG + F/TAF to B/F/TAF
Serious events: 32 serious events
Other events: 163 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
B/F/TAF
n=320 participants at risk
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=325 participants at risk
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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=254 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.
|
DTG + F/TAF to B/F/TAF
n=265 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.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.94%
3/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.62%
2/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.62%
2/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Disseminated intravascular coagulation
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Angina pectoris
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.75%
2/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 flutter
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 arrest
|
0.62%
2/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 congestive
|
0.62%
2/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Hypertensive heart disease
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Supraventricular tachycardia
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Thyroid mass
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Iridocyclitis
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 upper
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Anal fissure
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Anal fistula
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Anal ulcer
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Colitis
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Gastritis
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Hiatus hernia
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.62%
2/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Proctalgia
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Proctitis
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Rectal haemorrhage
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.62%
2/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Volvulus
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.62%
2/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.75%
2/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Hyperthermia
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Multiple organ dysfunction syndrome
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Oedema peripheral
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Systemic inflammatory response syndrome
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 acute
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 neck
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Amoebic dysentery
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.94%
3/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 infection
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.94%
3/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.62%
2/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Bacterial infection
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Blister infected
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
1.9%
6/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.75%
2/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Endocarditis
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Enteritis infectious
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Erysipelas
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Escherichia bacteraemia
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Eye infection syphilitic
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 shigella
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Herpes zoster
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 streptococcal
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Pilonidal cyst
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
4/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.75%
2/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 parainfluenzae viral
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Pyelonephritis
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.62%
2/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Shigella infection
|
0.62%
2/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Skin infection
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Staphylococcal infection
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Subcutaneous abscess
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Urinary tract infection
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Urosepsis
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Concussion
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Fall
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Foot fracture
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Gun shot wound
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Hand fracture
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Head injury
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Heat stroke
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Radius fracture
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Rectal injury
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Rib fracture
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.62%
2/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Subdural haematoma
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Tendon injury
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Ulna fracture
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Wound dehiscence
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Transaminases increased
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Fluid overload
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Hyperglycaemia
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Hypoglycaemia
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Hypokalaemia
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Metabolic acidosis
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Bursitis
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Cervical spinal stenosis
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Hip deformity
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 displacement
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.62%
2/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Muscle haemorrhage
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Muscle tightness
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Rhabdomyolysis
|
0.94%
3/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Spinal osteoarthritis
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Vertebral foraminal stenosis
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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)
Adenocarcinoma gastric
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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)
B-cell lymphoma
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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)
Bladder cancer
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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)
Central nervous system lymphoma
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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)
Colon cancer
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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)
Invasive ductal breast carcinoma
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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)
Lung neoplasm malignant
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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)
Lymphoma
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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)
Malignant melanoma
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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)
Pleomorphic adenoma
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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)
Thyroid cancer
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Cerebrovascular accident
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.62%
2/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Cervical radiculopathy
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Cubital tunnel syndrome
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Loss of consciousness
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Syncope
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Vertebral artery stenosis
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 incomplete
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Acute psychosis
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 disorder
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 suicidal
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 abuse
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Seasonal affective disorder
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Stress
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Substance use disorder
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Substance-induced psychotic disorder
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.62%
2/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Haematuria
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Ovarian cyst
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Chronic obstructive pulmonary disease
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.62%
2/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Interstitial lung disease
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Pneumothorax
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 mass
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Tonsillar disorder
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Skin ulcer
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Oesophagogastric fundoplasty
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.62%
2/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.62%
2/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Hypertensive crisis
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.31%
1/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Hypertensive emergency
|
0.00%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
0.31%
1/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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=320 participants at risk
Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
|
DTG + F/TAF
n=325 participants at risk
Blinded Phase: DTG (50 mg) + F/TAF (200/25 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=254 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.
|
DTG + F/TAF to B/F/TAF
n=265 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.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.5%
24/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
23/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
1.1%
3/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
7.2%
23/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
23/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.6%
7/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 upper
|
5.0%
16/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
13/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.75%
2/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
5.0%
16/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
4.6%
15/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
1.1%
3/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
20.6%
66/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
16.6%
54/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
5.7%
15/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Dyspepsia
|
6.6%
21/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
14/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
1.9%
5/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
9.7%
31/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
13.2%
43/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
4.2%
11/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Toothache
|
5.0%
16/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
9/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
1.1%
3/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
7.2%
23/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
6.8%
22/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
1.9%
5/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
9.1%
29/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
11.4%
37/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
4.9%
13/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
6.6%
21/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
31/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.4%
9/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
5.6%
18/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
18/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.0%
8/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
4.7%
15/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
28/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.9%
10/254 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.6%
7/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
4.4%
14/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
8.0%
26/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.3%
6/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
0/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.00%
0/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
26/254 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
11.7%
31/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
4.7%
15/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
18/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.0%
8/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
5.6%
18/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
7.4%
24/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
1.5%
4/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
8.4%
27/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
7.4%
24/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
4.2%
11/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
15.9%
51/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
19.1%
62/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
8.3%
22/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
6.9%
22/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.4%
11/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
3.8%
12/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
17/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.0%
8/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
7.8%
25/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
10/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.9%
10/254 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
1.9%
5/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
10.6%
34/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
33/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
20/254 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
6.4%
17/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
13.8%
44/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
16.6%
54/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
6.4%
17/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
Urinary tract infection
|
5.9%
19/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
14/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.4%
9/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
11.2%
36/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
33/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
16/254 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
6.4%
17/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
9.4%
30/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
13.5%
44/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
18/254 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
4.5%
12/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
8.4%
27/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.4%
11/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
4.9%
13/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
5.6%
18/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.4%
11/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.3%
6/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
5.3%
17/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
6.2%
20/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
1.9%
5/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
17.8%
57/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
18.2%
59/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
16/254 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
7.2%
19/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
5.0%
16/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
8.0%
26/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.4%
9/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
6.6%
21/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
8.0%
26/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.4%
9/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
9.1%
29/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
7.7%
25/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
5.3%
14/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
8.8%
28/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
30/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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%
16/254 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.4%
9/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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 congestion
|
5.3%
17/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.4%
11/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
0.38%
1/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
6.2%
20/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
5.8%
19/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
2.6%
7/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
4.7%
15/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
8.3%
27/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
4.2%
11/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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
|
5.9%
19/320 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
6.8%
22/325 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
|
3.0%
8/265 • Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
Adverse Events: Safety Analysis Set included all participants who were randomized into the 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