Trial Outcomes & Findings for Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC (NCT NCT02469246)
NCT ID: NCT02469246
Last Updated: 2019-10-25
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
567 participants
Primary outcome timeframe
Week 48
Results posted on
2019-10-25
Participant Flow
Participants were enrolled at study sites in North America and Europe. The first participant was screened on 29 June 2015. The last study visit occurred on 13 March 2019.
626 participants were screened.
Participant milestones
| Measure |
F/TAF
Double-Blind Phase: Emtricitabine/tenofovir alafenamide (F/TAF) (200/10 mg) fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral (ARV) agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + abacavir/lamivudine (ABC/3TC) placebo tablet once daily for 96 weeks, and continued blinded treatment until unblinding. \[Allowed boosted 3rd ARV agents: ritonavir boosted lopinavir (LPV/r), atazanavir (ATV) + ritonavir (RTV), ATV + cobicistat (COBI) or ATV/COBI FDC, darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC; Allowed unboosted 3rd ARV agents: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP)\].
Open-Label Extension: After the unblinding visit, in countries where F/TAF FDC was not commercially available, participants (except in certain countries) were given the option to receive the open-label F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country.
|
ABC/3TC
Double-Blind Phase: ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks, and continued blinded treatment until unblinding. (Allowed boosted 3rd ARV agents: LPV/r, ATV + RTV, ATV + COBI or ATV/COBI FDC, DRV + RTV, DRV+COBI or DRV/COBI FDC; Allowed unboosted 3rd ARV agents: EFV, RPV, RAL, DTG, MVC, or NVP)
Open-Label Extension: After the unblinding visit, in countries where F/TAF FDC was not commercially available, participants (except in certain countries) were given the option to receive the open-label F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country.
|
|---|---|---|
|
Double-Blind Phase
STARTED
|
285
|
282
|
|
Double-Blind Phase
COMPLETED
|
218
|
226
|
|
Double-Blind Phase
NOT COMPLETED
|
67
|
56
|
|
Open-Label Extension (OLE)
STARTED
|
6
|
5
|
|
Open-Label Extension (OLE)
COMPLETED
|
6
|
5
|
|
Open-Label Extension (OLE)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
F/TAF
Double-Blind Phase: Emtricitabine/tenofovir alafenamide (F/TAF) (200/10 mg) fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral (ARV) agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + abacavir/lamivudine (ABC/3TC) placebo tablet once daily for 96 weeks, and continued blinded treatment until unblinding. \[Allowed boosted 3rd ARV agents: ritonavir boosted lopinavir (LPV/r), atazanavir (ATV) + ritonavir (RTV), ATV + cobicistat (COBI) or ATV/COBI FDC, darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC; Allowed unboosted 3rd ARV agents: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP)\].
Open-Label Extension: After the unblinding visit, in countries where F/TAF FDC was not commercially available, participants (except in certain countries) were given the option to receive the open-label F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country.
|
ABC/3TC
Double-Blind Phase: ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks, and continued blinded treatment until unblinding. (Allowed boosted 3rd ARV agents: LPV/r, ATV + RTV, ATV + COBI or ATV/COBI FDC, DRV + RTV, DRV+COBI or DRV/COBI FDC; Allowed unboosted 3rd ARV agents: EFV, RPV, RAL, DTG, MVC, or NVP)
Open-Label Extension: After the unblinding visit, in countries where F/TAF FDC was not commercially available, participants (except in certain countries) were given the option to receive the open-label F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country.
|
|---|---|---|
|
Double-Blind Phase
Randomized and Never Treated
|
5
|
6
|
|
Double-Blind Phase
Adverse Event
|
12
|
9
|
|
Double-Blind Phase
Death
|
2
|
0
|
|
Double-Blind Phase
Lack of Efficacy
|
2
|
1
|
|
Double-Blind Phase
Investigator's Discretion
|
8
|
8
|
|
Double-Blind Phase
Non-Compliance with Study Drug
|
3
|
1
|
|
Double-Blind Phase
Protocol Violation
|
1
|
1
|
|
Double-Blind Phase
Withdrew Consent
|
25
|
25
|
|
Double-Blind Phase
Lost to Follow-up
|
9
|
5
|
Baseline Characteristics
Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC
Baseline characteristics by cohort
| Measure |
F/TAF
n=280 Participants
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
|
ABC/3TC
n=276 Participants
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
|
Total
n=556 Participants
Total of all reporting groups
|
|---|---|---|---|
|
CD4 Cell Count Category
≥ 500 cells/µL
|
204 Participants
n=93 Participants
|
221 Participants
n=4 Participants
|
425 Participants
n=27 Participants
|
|
HIV Disease Status
Asymptomatic
|
201 Participants
n=93 Participants
|
201 Participants
n=4 Participants
|
402 Participants
n=27 Participants
|
|
HIV Disease Status
Symptomatic HIV Infection
|
31 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 9.4 • n=93 Participants
|
51 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
51 years
STANDARD_DEVIATION 9.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
101 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
240 Participants
n=93 Participants
|
215 Participants
n=4 Participants
|
455 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
264 Participants
n=93 Participants
|
257 Participants
n=4 Participants
|
521 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
64 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
130 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
205 Participants
n=93 Participants
|
199 Participants
n=4 Participants
|
404 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
9 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Region of Enrollment
Denmark
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Region of Enrollment
France
|
18 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
20 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Region of Enrollment
Ireland
|
9 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
26 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
32 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Region of Enrollment
Sweden
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
50 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
109 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
105 Participants
n=93 Participants
|
101 Participants
n=4 Participants
|
206 Participants
n=27 Participants
|
|
HIV-1 RNA Category
< 50 copies/mL
|
278 Participants
n=93 Participants
|
273 Participants
n=4 Participants
|
551 Participants
n=27 Participants
|
|
HIV-1 RNA Category
≥ 50 copies/mL
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
CD4 Cell Count
|
703 cells/µL
STANDARD_DEVIATION 298.7 • n=93 Participants
|
727 cells/µL
STANDARD_DEVIATION 275.2 • n=4 Participants
|
715 cells/µL
STANDARD_DEVIATION 287.3 • n=27 Participants
|
|
CD4 Cell Count Category
< 50 cells/µL
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
CD4 Cell Count Category
≥ 50 to < 200 cells/µL
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
CD4 Cell Count Category
≥ 200 to < 350 cells/µL
|
20 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
CD4 Cell Count Category
≥ 350 to < 500 cells/µL
|
56 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
94 Participants
n=27 Participants
|
|
HIV Disease Status
AIDS
|
47 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
97 Participants
n=27 Participants
|
|
HIV Disease Status
Unknown
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: The Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. Participants were grouped according to the treatment to which they were randomized.
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 |
F/TAF
n=280 Participants
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
|
ABC/3TC
n=276 Participants
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
|
88.6 percentage of participants
|
92.4 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 |
F/TAF
n=280 Participants
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
|
ABC/3TC
n=276 Participants
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm
|
82.1 percentage of participants
|
88.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed.
The percentage of participants with 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 |
F/TAF
n=280 Participants
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
|
ABC/3TC
n=276 Participants
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
|
1.8 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 96Population: Participants in the Full Analysis Set were analyzed.
The percentage of participants with 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 |
F/TAF
n=280 Participants
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
|
ABC/3TC
n=276 Participants
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm
|
2.5 percentage of participants
|
1.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed.
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
F/TAF
n=280 Participants
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
|
ABC/3TC
n=276 Participants
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
|
85.7 percentage of participants
|
87.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 96Population: Participants in the Full Analysis Set were analyzed.
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Outcome measures
| Measure |
F/TAF
n=280 Participants
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
|
ABC/3TC
n=276 Participants
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm
|
80.4 percentage of participants
|
86.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
F/TAF
n=249 Participants
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
|
ABC/3TC
n=254 Participants
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
|
|---|---|---|
|
Change From Baseline in CD4 Cell Count at Week 48
|
-30 cells/µL
Standard Deviation 152.3
|
2 cells/µL
Standard Deviation 171.2
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
F/TAF
n=229 Participants
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
|
ABC/3TC
n=238 Participants
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
|
|---|---|---|
|
Change From Baseline in CD4 Cell Count at Week 96
|
-29 cells/μL
Standard Deviation 160.7
|
10 cells/μL
Standard Deviation 178.2
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set (all participants who are randomized and have received at least one dose of study drug, and have nonmissing baseline hip BMD values) with available data were analyzed.
Outcome measures
| Measure |
F/TAF
n=231 Participants
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
|
ABC/3TC
n=236 Participants
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
|
|---|---|---|
|
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
|
0.246 percent change
Standard Deviation 2.2914
|
0.086 percent change
Standard Deviation 2.3315
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Hip DXA Analysis Set with available data were analyzed.
Outcome measures
| Measure |
F/TAF
n=213 Participants
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
|
ABC/3TC
n=221 Participants
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
|
|---|---|---|
|
Percent Change From Baseline in Hip BMD at Week 96
|
0.169 percent change
Standard Deviation 2.7277
|
0.021 percent change
Standard Deviation 2.7212
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Spine DXA Analysis Set (all participants who are randomized and have received at least one dose of study drug, and have nonmissing baseline spine BMD values) with available data were analyzed.
Outcome measures
| Measure |
F/TAF
n=232 Participants
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
|
ABC/3TC
n=240 Participants
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
|
|---|---|---|
|
Percent Change From Baseline in Spine BMD at Week 48
|
0.081 percent change
Standard Deviation 3.0051
|
-0.052 percent change
Standard Deviation 3.7550
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Spine DXA Analysis Set with available data were analyzed.
Outcome measures
| Measure |
F/TAF
n=217 Participants
F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks
|
ABC/3TC
n=225 Participants
ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks
|
|---|---|---|
|
Percent Change From Baseline in Spine BMD at Week 96
|
0.178 percent change
Standard Deviation 3.8881
|
0.235 percent change
Standard Deviation 4.3066
|
Adverse Events
F/TAF (Double-Blind Phase)
Serious events: 55 serious events
Other events: 190 other events
Deaths: 5 deaths
ABC/3TC (Double-Blind Phase)
Serious events: 32 serious events
Other events: 199 other events
Deaths: 0 deaths
Open-Label F/TAF From F/TAF
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Open-Label F/TAF From ABC/3TC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
F/TAF (Double-Blind Phase)
n=280 participants at risk
Adverse events reported occurred during the Double-Blind Phase in participants from the F/TAF group, who received F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily.
|
ABC/3TC (Double-Blind Phase)
n=276 participants at risk
Adverse events reported occurred during the Double-Blind Phase in participants from the ABC/3TC group, who received ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent.
|
Open-Label F/TAF From F/TAF
n=6 participants at risk
Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the F/TAF group and received F/TAF (200/10 mg or 200/25 mg) FDC tablet once daily.
|
Open-Label F/TAF From ABC/3TC
n=5 participants at risk
Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the ABC/3TC group and received F/TAF (200/10 mg or 200/25 mg) FDC tablet once daily.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.71%
2/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Death
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Sudden cardiac death
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Abscess neck
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Acute hepatitis C
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Dengue fever
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Diarrhoea infectious
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Erysipelas
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.72%
2/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Groin abscess
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster oticus
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Peritonitis
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.8%
5/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.72%
2/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Urosepsis
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.72%
2/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Viral myocarditis
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Uterine perforation
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Transaminases increased
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Viral load increased
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.71%
2/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ganglioneuroma
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.71%
2/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral infarction
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Epilepsy
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Hydrocephalus
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Loss of consciousness
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Bipolar disorder
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Drug abuse
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Psychotic disorder
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Substance abuse
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.71%
2/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
3/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal colic
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
1.1%
3/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Social circumstances
Substance use
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.71%
2/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
1.1%
3/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
F/TAF (Double-Blind Phase)
n=280 participants at risk
Adverse events reported occurred during the Double-Blind Phase in participants from the F/TAF group, who received F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily.
|
ABC/3TC (Double-Blind Phase)
n=276 participants at risk
Adverse events reported occurred during the Double-Blind Phase in participants from the ABC/3TC group, who received ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent.
|
Open-Label F/TAF From F/TAF
n=6 participants at risk
Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the F/TAF group and received F/TAF (200/10 mg or 200/25 mg) FDC tablet once daily.
|
Open-Label F/TAF From ABC/3TC
n=5 participants at risk
Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the ABC/3TC group and received F/TAF (200/10 mg or 200/25 mg) FDC tablet once daily.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.7%
30/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
13.4%
37/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
14/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
4.0%
11/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
14/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
10/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
7.5%
21/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
15/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
6.8%
19/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
5.1%
14/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
3.9%
11/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
15/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
4.3%
12/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
15/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
20.4%
57/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
17.8%
49/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
20.0%
1/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Rhinitis
|
2.5%
7/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
2.2%
6/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
20.0%
1/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Syphilis
|
5.4%
15/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
5/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.9%
36/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
16.7%
46/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
4.6%
13/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
6.5%
18/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
28/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
10.5%
29/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.6%
24/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
11.2%
31/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.9%
11/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
5.1%
14/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.9%
22/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
15/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.36%
1/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
16.7%
1/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
11.1%
31/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
9.1%
25/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal colic
|
0.36%
1/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
20.0%
1/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.1%
34/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
10.9%
30/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
14/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
6.2%
17/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
5.4%
15/280 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
15/276 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/6 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/5 • First dose date to last dose date (maximum duration: 168 weeks) plus 30 days
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER