Trial Outcomes & Findings for Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) (NCT NCT02345252)
NCT ID: NCT02345252
Last Updated: 2020-01-02
Results Overview
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the US FDA-defined snapshot algorithm, which defines a patient'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
632 participants
Primary outcome timeframe
Week 48
Results posted on
2020-01-02
Participant Flow
Participants were enrolled at study sites in Europe and North America. The first participant was screened on 26 January 2015. The last study visit occurred on 09 January 2019.
690 participants were screened.
Participant milestones
| Measure |
FTC/RPV/TAF
Double-Blind Phase: Emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) (200/25/25 mg) fixed-dose combination (FDC) tablet + emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) placebo tablet orally once daily for up to 96 weeks.
Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first.
|
FTC/RPV/TDF
Double-Blind Phase: FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily and attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first.
|
|---|---|---|
|
Double-Blind Phase
STARTED
|
316
|
316
|
|
Double-Blind Phase
COMPLETED
|
276
|
267
|
|
Double-Blind Phase
NOT COMPLETED
|
40
|
49
|
|
Open-Label Extension Phase
STARTED
|
19
|
17
|
|
Open-Label Extension Phase
COMPLETED
|
19
|
17
|
|
Open-Label Extension Phase
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
FTC/RPV/TAF
Double-Blind Phase: Emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) (200/25/25 mg) fixed-dose combination (FDC) tablet + emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) placebo tablet orally once daily for up to 96 weeks.
Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first.
|
FTC/RPV/TDF
Double-Blind Phase: FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily and attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first.
|
|---|---|---|
|
Double-Blind Phase
Adverse Event
|
2
|
3
|
|
Double-Blind Phase
Death
|
1
|
2
|
|
Double-Blind Phase
Lack of Efficacy
|
1
|
0
|
|
Double-Blind Phase
Investigator's Discretion
|
4
|
6
|
|
Double-Blind Phase
Non-Compliance with Study Drug
|
1
|
2
|
|
Double-Blind Phase
Protocol Violation
|
2
|
1
|
|
Double-Blind Phase
Withdrew Consent
|
21
|
23
|
|
Double-Blind Phase
Lost to Follow-up
|
8
|
10
|
|
Double-Blind Phase
Randomized but Never Treated
|
0
|
2
|
Baseline Characteristics
Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)
Baseline characteristics by cohort
| Measure |
FTC/RPV/TAF
n=316 Participants
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
|
FTC/RPV/TDF
n=314 Participants
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
|
Total
n=630 Participants
Total of all reporting groups
|
|---|---|---|---|
|
CD4 Cell Count Category
≥ 50 to < 200 cells/µL
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
44 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
45 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
275 Participants
n=5 Participants
|
289 Participants
n=7 Participants
|
564 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
65 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
238 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
473 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
40 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
275 Participants
n=5 Participants
|
261 Participants
n=7 Participants
|
536 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
24 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
222 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
448 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
HIV-1 RNA Category
< 50 copies/mL
|
307 Participants
n=5 Participants
|
312 Participants
n=7 Participants
|
619 Participants
n=5 Participants
|
|
HIV-1 RNA Category
≥ 50 copies/mL
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
CD4 Cell Count
|
711 cells/μL
STANDARD_DEVIATION 278.9 • n=5 Participants
|
707 cells/μL
STANDARD_DEVIATION 264.7 • n=7 Participants
|
709 cells/μL
STANDARD_DEVIATION 271.7 • n=5 Participants
|
|
CD4 Cell Count Category
≥ 200 to < 350 cells/µL
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
CD4 Cell Count Category
≥ 350 to < 500 cells/µL
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
CD4 Cell Count Category
≥ 500 cells/ µL
|
249 Participants
n=5 Participants
|
247 Participants
n=7 Participants
|
496 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug and were on FTC/RPV/TDF prior to the screening visit.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the US FDA-defined snapshot algorithm, which defines a patient'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 |
FTC/RPV/TAF
n=316 Participants
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
|
FTC/RPV/TDF
n=313 Participants
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
|
93.7 percentage of participants
|
93.9 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 patient'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 |
FTC/RPV/TAF
n=316 Participants
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
|
FTC/RPV/TDF
n=313 Participants
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
|
0.6 percentage of participants
|
0 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 patient'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 |
FTC/RPV/TAF
n=316 Participants
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
|
FTC/RPV/TDF
n=313 Participants
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
|
0.6 percentage of participants
|
1.0 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 patient'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 |
FTC/RPV/TAF
n=316 Participants
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
|
FTC/RPV/TDF
n=313 Participants
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
|
89.2 percentage of participants
|
88.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Full Analysis Set with on-treatment data were analyzed.
Outcome measures
| Measure |
FTC/RPV/TAF
n=296 Participants
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
|
FTC/RPV/TDF
n=293 Participants
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 48
|
9 cells/µL
Standard Deviation 159.7
|
-1 cells/µL
Standard Deviation 152.7
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Full Analysis Set with on-treatment data were analyzed.
Outcome measures
| Measure |
FTC/RPV/TAF
n=283 Participants
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
|
FTC/RPV/TDF
n=277 Participants
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 96
|
12 cells/µL
Standard Deviation 180.6
|
16 cells/µL
Standard Deviation 171.9
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Hip DXA Analysis Set (all randomized participants who received at least 1 dose of study drug, and had nonmissing baseline hip BMD value) with available data were analyzed.
Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
Outcome measures
| Measure |
FTC/RPV/TAF
n=168 Participants
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
|
FTC/RPV/TDF
n=165 Participants
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
|
1.040 percentage change
Standard Deviation 1.9404
|
-0.245 percentage change
Standard Deviation 2.0805
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Hip DXA Analysis Set with available data were analyzed.
Hip BMD was assessed by DXA scan.
Outcome measures
| Measure |
FTC/RPV/TAF
n=160 Participants
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
|
FTC/RPV/TDF
n=156 Participants
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Hip BMD at Week 96
|
1.623 percentage change
Standard Deviation 2.4575
|
-0.613 percentage change
Standard Deviation 2.7411
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the spine DXA Analysis Set (all randomized participants who received at least 1 dose of study drug, and had nonmissing baseline hip BMD value) with available data were analyzed.
Spine BMD was assessed by DXA scan.
Outcome measures
| Measure |
FTC/RPV/TAF
n=172 Participants
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
|
FTC/RPV/TDF
n=168 Participants
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Spine BMD at Week 48
|
1.613 percentage change
Standard Deviation 3.4346
|
0.075 percentage change
Standard Deviation 2.9605
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Spine DXA Analysis Set with available data were analyzed.
Spine BMD was assessed by DXA scan.
Outcome measures
| Measure |
FTC/RPV/TAF
n=162 Participants
FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
|
FTC/RPV/TDF
n=158 Participants
FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Spine BMD at Week 96
|
2.039 percentage change
Standard Deviation 3.5098
|
-0.250 percentage change
Standard Deviation 3.5903
|
Adverse Events
FTC/RPV/TAF (Double-Blind Phase)
Serious events: 36 serious events
Other events: 249 other events
Deaths: 1 deaths
FTC/RPV/TDF (Double-Blind Phase)
Serious events: 29 serious events
Other events: 234 other events
Deaths: 2 deaths
Open-Label FTC/RPV/TAF From FTC/RPV/TAF
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Open-Label FTC/RPV/TAF From FTC/RPV/TDF
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FTC/RPV/TAF (Double-Blind Phase)
n=316 participants at risk
Adverse events reported occurred during the Double-Blind Phase in participants from the FTC/RPV/TAF group, who received FTC/RPV/TAF (200/25/25 mg) FDC tablet plus FTC/RPV/TDF placebo tablet administered orally once daily.
|
FTC/RPV/TDF (Double-Blind Phase)
n=314 participants at risk
Adverse events reported occurred during the Double-Blind Phase in participants from the FTC/RPV/TDF group, who received FTC/RPV/TDF (200/25/300 mg) FDC tablet plus FTC/RPV/TAF placebo tablet administered orally once daily.
|
Open-Label FTC/RPV/TAF From FTC/RPV/TAF
n=19 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 FTC/RPV/TAF group and received FTC/RPV/TAF (200/25/25 mg) FDC tablet once daily.
|
Open-Label FTC/RPV/TAF From FTC/RPV/TDF
n=17 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 FTC/RPV/TDF group and received FTC/RPV/TAF (200/25/25 mg) FDC tablet once daily.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Generalised oedema
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Abscess limb
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Anal chlamydia infection
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.3%
4/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.95%
3/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.64%
2/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis cryptosporidial
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Helicobacter infection
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Myelitis
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Osteomyelitis
|
0.63%
2/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Proctitis gonococcal
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Syphilis
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hyphaema
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.63%
2/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.63%
2/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression suicidal
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Major depression
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
0.63%
2/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Calculus urethral
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal colic
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Priapism
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.64%
2/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.95%
3/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Social circumstances
Substance use
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.63%
2/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
FTC/RPV/TAF (Double-Blind Phase)
n=316 participants at risk
Adverse events reported occurred during the Double-Blind Phase in participants from the FTC/RPV/TAF group, who received FTC/RPV/TAF (200/25/25 mg) FDC tablet plus FTC/RPV/TDF placebo tablet administered orally once daily.
|
FTC/RPV/TDF (Double-Blind Phase)
n=314 participants at risk
Adverse events reported occurred during the Double-Blind Phase in participants from the FTC/RPV/TDF group, who received FTC/RPV/TDF (200/25/300 mg) FDC tablet plus FTC/RPV/TAF placebo tablet administered orally once daily.
|
Open-Label FTC/RPV/TAF From FTC/RPV/TAF
n=19 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 FTC/RPV/TAF group and received FTC/RPV/TAF (200/25/25 mg) FDC tablet once daily.
|
Open-Label FTC/RPV/TAF From FTC/RPV/TDF
n=17 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 FTC/RPV/TDF group and received FTC/RPV/TAF (200/25/25 mg) FDC tablet once daily.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.6%
5/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.96%
3/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Eye disorders
Blepharitis
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
10.5%
2/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Eye disorders
Eye pain
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Eye disorders
Meibomianitis
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Eye disorders
Retinal detachment
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
6/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.9%
6/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.8%
34/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
12.7%
40/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
11.8%
2/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
1.6%
5/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
2.5%
8/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.63%
2/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
6.3%
20/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.5%
11/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
17/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.2%
10/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
5.4%
17/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.9%
28/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
0.63%
2/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.96%
3/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
2.2%
7/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
4.1%
13/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
17.6%
3/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
2.2%
7/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.6%
5/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Anal chlamydia infection
|
0.95%
3/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
2.9%
9/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
7.0%
22/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
7.3%
23/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Chlamydial infection
|
3.2%
10/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
2.5%
8/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Fungal skin infection
|
0.95%
3/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.3%
4/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
3.2%
10/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.5%
11/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Genital herpes
|
0.95%
3/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.6%
5/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
6.0%
19/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.7%
18/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
15.5%
49/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
14.6%
46/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
17.6%
3/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Onychomycosis
|
1.3%
4/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.9%
6/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Oral herpes
|
1.9%
6/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.96%
3/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
10.5%
2/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Papilloma viral infection
|
0.63%
2/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.64%
2/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
4.4%
14/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
4.1%
13/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.9%
6/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.95%
3/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.64%
2/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Rhinitis
|
1.6%
5/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.64%
2/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
6.3%
20/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
7.3%
23/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Syphilis
|
5.1%
16/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
7.3%
23/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Tooth infection
|
1.6%
5/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.9%
6/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.9%
47/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
14.6%
46/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.2%
10/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.6%
5/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.96%
3/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
0.95%
3/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.96%
3/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.6%
24/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
10.2%
32/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.9%
28/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
10.8%
34/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
10.5%
2/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.3%
4/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.3%
4/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.2%
10/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
2.9%
9/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
11.8%
2/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.5%
11/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.3%
4/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.9%
25/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.1%
16/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.63%
2/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
10.5%
2/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
3.5%
11/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.5%
11/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.96%
3/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
7.9%
25/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
7.6%
24/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
11.8%
2/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
2.5%
8/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
2.2%
7/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Sciatica
|
1.3%
4/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.63%
2/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.64%
2/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
5.4%
17/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
4.1%
13/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depressed mood
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.64%
2/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
6.3%
20/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
4.1%
13/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
3.5%
11/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.7%
18/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Sleep sex
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
1.6%
5/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.6%
5/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.8%
9/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.32%
1/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.9%
6/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.3%
4/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.0%
22/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
7.6%
24/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
10.5%
2/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
17.6%
3/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.5%
8/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.96%
3/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.9%
6/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.3%
4/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
5/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.64%
2/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.64%
2/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.32%
1/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.3%
1/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
7.0%
22/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
2.9%
9/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Varicose vein
|
0.63%
2/316 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/314 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/19 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.9%
1/17 • First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
The Safety Analysis Set included 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