Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults (NCT NCT01797445)
NCT ID: NCT01797445
Last Updated: 2020-03-02
Results Overview
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a 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
872 participants
Primary outcome timeframe
Week 48
Results posted on
2020-03-02
Participant Flow
Participants were enrolled at study sites in North America and Europe. The first participant was screened on 12 March 2013. The last study visit occurred on 03 October 2018.
1070 participants were screened.
Participant milestones
| Measure |
E/C/F/TAF
Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) placebo tablet administered orally once daily for 144 weeks.
Open-Label Extension Phase: After the unblinding visit, in countries where E/C/F/TAF FDC was not commercially available, participants (except in UK) were given the option to receive the open-label E/C/F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country.
|
E/C/F/TDF
Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks.
Open-Label Extension Phase: After the unblinding visit, in countries where E/C/F/TAF FDC was not commercially available, participants (except in UK) were given the option to receive the open-label E/C/F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country.
|
|---|---|---|
|
Double-Blind Phase
STARTED
|
435
|
437
|
|
Double-Blind Phase
COMPLETED
|
348
|
348
|
|
Double-Blind Phase
NOT COMPLETED
|
87
|
89
|
|
Open-Label Extension Phase
STARTED
|
141
|
119
|
|
Open-Label Extension Phase
COMPLETED
|
140
|
119
|
|
Open-Label Extension Phase
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
E/C/F/TAF
Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) placebo tablet administered orally once daily for 144 weeks.
Open-Label Extension Phase: After the unblinding visit, in countries where E/C/F/TAF FDC was not commercially available, participants (except in UK) were given the option to receive the open-label E/C/F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country.
|
E/C/F/TDF
Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks.
Open-Label Extension Phase: After the unblinding visit, in countries where E/C/F/TAF FDC was not commercially available, participants (except in UK) were given the option to receive the open-label E/C/F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country.
|
|---|---|---|
|
Double-Blind Phase
Randomized but Not Treated
|
4
|
2
|
|
Double-Blind Phase
Adverse Event
|
3
|
0
|
|
Double-Blind Phase
Death
|
5
|
4
|
|
Double-Blind Phase
Pregnancy
|
0
|
1
|
|
Double-Blind Phase
Lack of Efficacy
|
1
|
2
|
|
Double-Blind Phase
Investigator's Discretion
|
15
|
17
|
|
Double-Blind Phase
Noncompliance with Study Drug
|
5
|
1
|
|
Double-Blind Phase
Protocol Violation
|
0
|
1
|
|
Double-Blind Phase
Withdrew Consent
|
20
|
35
|
|
Double-Blind Phase
Lost to Follow-up
|
34
|
26
|
|
Open-Label Extension Phase
Investigator's Discretion
|
1
|
0
|
Baseline Characteristics
Participants in the Safety Analysis Set with available data were analyzed (E/C/F/TAF: N = 430; E/C/F/TDF: N = 435)
Baseline characteristics by cohort
| Measure |
E/C/F/TAF
n=431 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=435 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
Total
n=866 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 10.8 • n=431 Participants
|
36 years
STANDARD_DEVIATION 10.9 • n=435 Participants
|
36 years
STANDARD_DEVIATION 10.9 • n=866 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=431 Participants
|
71 Participants
n=435 Participants
|
133 Participants
n=866 Participants
|
|
Sex: Female, Male
Male
|
369 Participants
n=431 Participants
|
364 Participants
n=435 Participants
|
733 Participants
n=866 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=431 Participants
|
3 Participants
n=435 Participants
|
4 Participants
n=866 Participants
|
|
Race/Ethnicity, Customized
Asian
|
15 Participants
n=431 Participants
|
12 Participants
n=435 Participants
|
27 Participants
n=866 Participants
|
|
Race/Ethnicity, Customized
Black
|
129 Participants
n=431 Participants
|
132 Participants
n=435 Participants
|
261 Participants
n=866 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
4 Participants
n=431 Participants
|
1 Participants
n=435 Participants
|
5 Participants
n=866 Participants
|
|
Race/Ethnicity, Customized
White
|
235 Participants
n=431 Participants
|
243 Participants
n=435 Participants
|
478 Participants
n=866 Participants
|
|
Race/Ethnicity, Customized
Other
|
47 Participants
n=431 Participants
|
44 Participants
n=435 Participants
|
91 Participants
n=866 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
107 Participants
n=431 Participants
|
97 Participants
n=435 Participants
|
204 Participants
n=866 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
323 Participants
n=431 Participants
|
336 Participants
n=435 Participants
|
659 Participants
n=866 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
1 Participants
n=431 Participants
|
1 Participants
n=435 Participants
|
2 Participants
n=866 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=431 Participants
|
1 Participants
n=435 Participants
|
1 Participants
n=866 Participants
|
|
Region of Enrollment
United States
|
280 Participants
n=431 Participants
|
282 Participants
n=435 Participants
|
562 Participants
n=866 Participants
|
|
Region of Enrollment
United Kingdom
|
25 Participants
n=431 Participants
|
31 Participants
n=435 Participants
|
56 Participants
n=866 Participants
|
|
Region of Enrollment
Portugal
|
21 Participants
n=431 Participants
|
16 Participants
n=435 Participants
|
37 Participants
n=866 Participants
|
|
Region of Enrollment
Canada
|
19 Participants
n=431 Participants
|
22 Participants
n=435 Participants
|
41 Participants
n=866 Participants
|
|
Region of Enrollment
Netherlands
|
6 Participants
n=431 Participants
|
8 Participants
n=435 Participants
|
14 Participants
n=866 Participants
|
|
Region of Enrollment
Sweden
|
8 Participants
n=431 Participants
|
3 Participants
n=435 Participants
|
11 Participants
n=866 Participants
|
|
Region of Enrollment
Dominican Republic
|
30 Participants
n=431 Participants
|
35 Participants
n=435 Participants
|
65 Participants
n=866 Participants
|
|
Region of Enrollment
Italy
|
10 Participants
n=431 Participants
|
8 Participants
n=435 Participants
|
18 Participants
n=866 Participants
|
|
Region of Enrollment
Mexico
|
16 Participants
n=431 Participants
|
12 Participants
n=435 Participants
|
28 Participants
n=866 Participants
|
|
Region of Enrollment
France
|
16 Participants
n=431 Participants
|
18 Participants
n=435 Participants
|
34 Participants
n=866 Participants
|
|
HIV-1 RNA
|
4.53 log10 copies/mL
STANDARD_DEVIATION 0.647 • n=431 Participants
|
4.50 log10 copies/mL
STANDARD_DEVIATION 0.690 • n=435 Participants
|
4.52 log10 copies/mL
STANDARD_DEVIATION 0.669 • n=866 Participants
|
|
HIV-1 RNA Category
≤ 100,000 copies/mL
|
339 Participants
n=431 Participants
|
336 Participants
n=435 Participants
|
675 Participants
n=866 Participants
|
|
HIV-1 RNA Category
> 100,000 to ≤ 400,000 copies/mL
|
68 Participants
n=431 Participants
|
82 Participants
n=435 Participants
|
150 Participants
n=866 Participants
|
|
HIV-1 RNA Category
> 400,000 copies/mL
|
24 Participants
n=431 Participants
|
17 Participants
n=435 Participants
|
41 Participants
n=866 Participants
|
|
CD4 Cell Count
|
414 cells/µL
STANDARD_DEVIATION 206.8 • n=430 Participants • Participants in the Safety Analysis Set with available data were analyzed (E/C/F/TAF: N = 430; E/C/F/TDF: N = 435)
|
431 cells/µL
STANDARD_DEVIATION 226.8 • n=435 Participants • Participants in the Safety Analysis Set with available data were analyzed (E/C/F/TAF: N = 430; E/C/F/TDF: N = 435)
|
423 cells/µL
STANDARD_DEVIATION 217.1 • n=865 Participants • Participants in the Safety Analysis Set with available data were analyzed (E/C/F/TAF: N = 430; E/C/F/TDF: N = 435)
|
|
CD4 Cell Count Category
< 50 cells/μL
|
14 Participants
n=431 Participants
|
15 Participants
n=435 Participants
|
29 Participants
n=866 Participants
|
|
CD4 Cell Count Category
≥ 50 to < 200 cells/μL
|
40 Participants
n=431 Participants
|
49 Participants
n=435 Participants
|
89 Participants
n=866 Participants
|
|
CD4 Cell Count Category
≥ 200 to < 350 cells/μL
|
115 Participants
n=431 Participants
|
89 Participants
n=435 Participants
|
204 Participants
n=866 Participants
|
|
CD4 Cell Count Category
≥ 350 to < 500 cells/μL
|
134 Participants
n=431 Participants
|
149 Participants
n=435 Participants
|
283 Participants
n=866 Participants
|
|
CD4 Cell Count Category
≥ 500 cells/μL
|
127 Participants
n=431 Participants
|
133 Participants
n=435 Participants
|
260 Participants
n=866 Participants
|
|
CD4 Cell Count Category
Missing
|
1 Participants
n=431 Participants
|
0 Participants
n=435 Participants
|
1 Participants
n=866 Participants
|
|
HIV Disease Status
Asymptomatic
|
377 Participants
n=431 Participants
|
394 Participants
n=435 Participants
|
771 Participants
n=866 Participants
|
|
HIV Disease Status
Symptomatic HIV Infection
|
30 Participants
n=431 Participants
|
19 Participants
n=435 Participants
|
49 Participants
n=866 Participants
|
|
HIV Disease Status
AIDS
|
22 Participants
n=431 Participants
|
19 Participants
n=435 Participants
|
41 Participants
n=866 Participants
|
|
HIV Disease Status
Unknown
|
2 Participants
n=431 Participants
|
3 Participants
n=435 Participants
|
5 Participants
n=866 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a 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 |
E/C/F/TAF
n=431 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=435 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
|---|---|---|
|
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48
|
91.6 percentage of participants
|
88.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 96Population: Participants in the Full Analysis Set were analyzed.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a 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 |
E/C/F/TAF
n=431 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=435 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
|
84.0 percentage of participants
|
82.3 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 48 and 96Population: Participants in the Full Analysis Set were analyzed.
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Weeks 48 and 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 |
E/C/F/TAF
n=431 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=435 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96
Week 48
|
82.4 percentage of participants
|
80.7 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96
Week 96
|
78.7 percentage of participants
|
76.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
E/C/F/TAF
n=404 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=400 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 48
|
225 cells/µL
Standard Deviation 171.2
|
200 cells/µL
Standard Deviation 162.5
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
E/C/F/TAF
n=369 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=369 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 96
|
274 cells/µL
Standard Deviation 184.0
|
260 cells/µL
Standard Deviation 179.6
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: The Hip DXA Analysis Set included all participants who were randomized and received at least 1 dose of study drug, and have nonmissing baseline hip BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
Outcome measures
| Measure |
E/C/F/TAF
n=380 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=381 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
|---|---|---|
|
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
|
-0.420 percent change
Standard Deviation 3.2268
|
-2.603 percent change
Standard Deviation 3.1482
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Hip DXA Analysis Set were analyzed. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
Hip BMD was assessed by DXA scan.
Outcome measures
| Measure |
E/C/F/TAF
n=341 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=346 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
|---|---|---|
|
Percent Change From Baseline in Hip BMD at Week 96
|
-0.364 percent change
Standard Deviation 3.8990
|
-3.023 percent change
Standard Deviation 3.9796
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: The Spine DXA Analysis Set included all participants who were randomized and received at least 1 dose of study drug, and have nonmissing baseline spine BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
Spine BMD was assessed by DXA scan.
Outcome measures
| Measure |
E/C/F/TAF
n=386 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=385 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
|---|---|---|
|
Percent Change From Baseline in Spine BMD at Week 48
|
-1.278 percent change
Standard Deviation 3.0098
|
-2.759 percent change
Standard Deviation 3.0024
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Spine DXA Analysis Set were analyzed. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
Spine BMD was assessed by DXA scan.
Outcome measures
| Measure |
E/C/F/TAF
n=346 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=347 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
|---|---|---|
|
Percent Change From Baseline in Spine BMD at Week 96
|
-1.017 percent change
Standard Deviation 3.3957
|
-2.516 percent change
Standard Deviation 3.8612
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
Outcome measures
| Measure |
E/C/F/TAF
n=405 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=402 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
|---|---|---|
|
Change From Baseline in Serum Creatinine at Week 48
|
0.08 mg/dL
Standard Deviation 0.136
|
0.12 mg/dL
Standard Deviation 0.283
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Safety Analysis Set were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.
Outcome measures
| Measure |
E/C/F/TAF
n=373 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=370 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
|---|---|---|
|
Change From Baseline in Serum Creatinine at Week 96
|
0.04 mg/dL
Standard Deviation 0.119
|
0.07 mg/dL
Standard Deviation 0.122
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.
Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.
Outcome measures
| Measure |
E/C/F/TAF
n=428 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=434 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Proteinuria Through Week 48
Grade 1
|
27.3 percentage of participants
|
31.6 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Proteinuria Through Week 48
Grade 2
|
4.7 percentage of participants
|
4.6 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Proteinuria Through Week 48
Grade 3
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 96Population: Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.
Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.
Outcome measures
| Measure |
E/C/F/TAF
n=428 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=434 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Proteinuria Through Week 96
Grade 1
|
31.8 percentage of participants
|
36.9 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Proteinuria Through Week 96
Grade 2
|
5.4 percentage of participants
|
5.1 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Proteinuria Through Week 96
Grade 3
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Safety Analysis Set with available data were analyzed.
Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Outcome measures
| Measure |
E/C/F/TAF
n=400 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=397 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
|---|---|---|
|
Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48
|
13.3 percent change
Interval -22.6 to 52.4
|
51.7 percent change
Interval 2.6 to 138.6
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Safety Analysis Set with available data were analyzed.
Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Outcome measures
| Measure |
E/C/F/TAF
n=379 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=363 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
|---|---|---|
|
Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96
|
16.9 percent change
Interval -18.6 to 72.4
|
73.7 percent change
Interval 10.4 to 196.3
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Safety Analysis Set with available data were analyzed.
Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
Outcome measures
| Measure |
E/C/F/TAF
n=395 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=392 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
|---|---|---|
|
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48
|
-29.3 percent change
Interval -55.1 to 6.1
|
32.3 percent change
Interval -36.4 to 159.9
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Safety Analysis Set with available data were analyzed.
Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
Outcome measures
| Measure |
E/C/F/TAF
n=375 Participants
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
|
E/C/F/TDF
n=360 Participants
E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
|
|---|---|---|
|
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96
|
-31.0 percent change
Interval -62.7 to 6.1
|
35.2 percent change
Interval -27.5 to 248.8
|
Adverse Events
E/C/F/TAF (Double-Blind Phase)
Serious events: 54 serious events
Other events: 374 other events
Deaths: 5 deaths
E/C/F/TDF (Double-Blind Phase)
Serious events: 68 serious events
Other events: 366 other events
Deaths: 4 deaths
Open-Label E/C/F/TAF From E/C/F/TAF
Serious events: 4 serious events
Other events: 32 other events
Deaths: 0 deaths
Open-Label E/C/F/TAF From E/C/F/TDF
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E/C/F/TAF (Double-Blind Phase)
n=431 participants at risk
Adverse events reported occurred during the Double-Blind Phase in participants from the E/C/F/TAF group, who received E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks.
|
E/C/F/TDF (Double-Blind Phase)
n=435 participants at risk
Adverse events reported occurred during the Double-Blind Phase in participants from the E/C/F/TDF group, who received E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks.
|
Open-Label E/C/F/TAF From E/C/F/TAF
n=141 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 E/C/F/TAF group and received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily.
|
Open-Label E/C/F/TAF From E/C/F/TDF
n=119 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 E/C/F/TDF group and received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily.
|
|---|---|---|---|---|
|
Psychiatric disorders
Major depression
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Psychotic disorder
|
0.46%
2/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.46%
2/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.46%
2/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.46%
2/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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 haematoma
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Febrile neutropenia
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Leukocytosis
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Sickle cell anaemia with crisis
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Endocrine disorders
Goitre
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Palatal dysplasia
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.69%
3/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.46%
2/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.69%
3/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Death
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.46%
2/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.46%
2/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Immune system disorders
Immune reconstitution inflammatory syndrome
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.46%
2/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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 abscess
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.84%
1/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.92%
4/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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 perforated
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.46%
2/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Chorioretinitis
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Diarrhoea infectious
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Encephalitis
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Erysipelas
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.93%
4/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Lung abscess
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Mastoiditis
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Meningitis
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Meningitis meningococcal
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Orchitis
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Otitis externa
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Otitis media
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Penile abscess
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Periorbital cellulitis
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Perirectal abscess
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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 streptococcal
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.46%
2/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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 necrotising
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.46%
2/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Secondary syphilis
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Shigella infection
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.46%
2/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.84%
1/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.46%
2/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
West Nile viral infection
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Wound infection
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Alcohol poisoning
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Ankle fracture
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Cervical vertebral fracture
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Femur fracture
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Gun shot wound
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Labelled drug-drug interaction medication error
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Muscle strain
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.69%
3/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Postoperative respiratory failure
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Rib fracture
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Road traffic accident
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Spinal fracture
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Stab wound
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Subarachnoid haemorrhage
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Thoracic vertebral fracture
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.46%
2/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Traumatic liver injury
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Wound
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase abnormal
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Osteonecrosis
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.46%
2/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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)
Adenocarcinoma of colon
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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)
Anal squamous cell carcinoma
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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)
Cervix carcinoma
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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)
Hodgkin's disease
|
0.46%
2/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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)
Lymphoma
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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)
Lymphoproliferative disorder
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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)
Meningioma
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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)
Metastases to liver
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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)
Prostate cancer
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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)
Uterine leiomyoma
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Nerve compression
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Acute psychosis
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Bipolar II disorder
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.46%
2/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.69%
3/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.46%
2/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Homicidal ideation
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Ureterolithiasis
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Vaginal dysplasia
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Acute respiratory failure
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
0.70%
3/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Bronchospasm
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Dyspnoea
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Pneumomediastinum
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Pneumonia aspiration
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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 oedema
|
0.00%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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%
0/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Hidradenitis
|
0.23%
1/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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 |
E/C/F/TAF (Double-Blind Phase)
n=431 participants at risk
Adverse events reported occurred during the Double-Blind Phase in participants from the E/C/F/TAF group, who received E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks.
|
E/C/F/TDF (Double-Blind Phase)
n=435 participants at risk
Adverse events reported occurred during the Double-Blind Phase in participants from the E/C/F/TDF group, who received E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks.
|
Open-Label E/C/F/TAF From E/C/F/TAF
n=141 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 E/C/F/TAF group and received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily.
|
Open-Label E/C/F/TAF From E/C/F/TDF
n=119 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 E/C/F/TDF group and received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.7%
29/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.5%
24/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.4%
2/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.7%
2/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
7.7%
33/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
7.8%
34/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.7%
2/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
5.6%
24/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
7.6%
33/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.0%
99/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
26.2%
114/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.7%
2/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
23/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.4%
15/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.0%
26/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.2%
27/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.84%
1/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
18.1%
78/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
19.8%
86/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.7%
2/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
6.0%
26/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
4.4%
19/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.84%
1/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
10.2%
44/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
10.6%
46/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.7%
2/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
12.3%
53/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
12.0%
52/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
8.6%
37/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
7.4%
32/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
8.8%
38/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.0%
26/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.4%
2/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.84%
1/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
5.6%
24/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
4.6%
20/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Folliculitis
|
4.4%
19/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.0%
26/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.4%
2/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
5.3%
23/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
4.8%
21/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.7%
2/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Gonorrhoea
|
6.0%
26/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
4.6%
20/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
5.8%
25/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
4.1%
18/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.7%
2/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
15.8%
68/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
17.2%
75/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
3.5%
5/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
4.2%
5/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
5.1%
22/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.7%
25/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
5.8%
25/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.4%
28/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.4%
2/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.84%
1/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
9.7%
42/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
10.1%
44/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.4%
2/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
2.5%
3/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
20.2%
87/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
18.9%
82/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.4%
2/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.7%
2/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
3.9%
17/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
7.1%
31/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.7%
2/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
14.2%
61/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
11.3%
49/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.4%
2/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
14.6%
63/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
12.2%
53/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Osteopenia
|
7.9%
34/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.7%
38/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.4%
2/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.84%
1/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
7.2%
31/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.0%
26/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.4%
2/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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)
Anogenital warts
|
6.7%
29/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.7%
25/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.84%
1/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
6.3%
27/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.4%
28/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
22.7%
98/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
18.4%
80/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
2.8%
4/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
1.7%
2/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
7.9%
34/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
9.9%
43/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
7.9%
34/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
6.0%
26/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.84%
1/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
11.8%
51/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
8.5%
37/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Proteinuria
|
2.6%
11/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.1%
22/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
14.4%
62/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
11.3%
49/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
2.5%
3/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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 congestion
|
3.7%
16/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
5.1%
22/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
Oropharyngeal pain
|
5.8%
25/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
9.0%
39/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) 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
|
10.9%
47/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
9.7%
42/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.71%
1/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
6.0%
26/431 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
2.5%
11/435 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/141 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/119 • First dose date to last dose date (maximum duration: 185 weeks during Double-Blind Phase and 102 weeks during Open-Label Extension Phase) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
Additional Information
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