Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults (NCT NCT01780506)
NCT ID: NCT01780506
Last Updated: 2018-11-19
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
2018-11-19
Participant Flow
Participants were enrolled at study sites in North America, Europe, and Asia. The first participant was screened on 26 December 2012. The last study visit occurred on 06 September 2017.
1105 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 at least 144 weeks.
Open-Label Extension Phase: After study unblinding, participants who completed 144 weeks of the study were given the option to receive open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available, or until Gilead Sciences 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 at least 144 weeks.
Open-Label Extension Phase: After study unblinding, participants who completed 144 weeks of the study were given the option to receive open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available, or until Gilead Sciences terminated the study in that country.
|
|---|---|---|
|
Double-Blind Phase
STARTED
|
438
|
434
|
|
Double-Blind Phase
COMPLETED
|
368
|
356
|
|
Double-Blind Phase
NOT COMPLETED
|
70
|
78
|
|
Open-Label Extension Phase
STARTED
|
90
|
95
|
|
Open-Label Extension Phase
COMPLETED
|
90
|
94
|
|
Open-Label Extension Phase
NOT COMPLETED
|
0
|
1
|
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 at least 144 weeks.
Open-Label Extension Phase: After study unblinding, participants who completed 144 weeks of the study were given the option to receive open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available, or until Gilead Sciences 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 at least 144 weeks.
Open-Label Extension Phase: After study unblinding, participants who completed 144 weeks of the study were given the option to receive open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available, or until Gilead Sciences terminated the study in that country.
|
|---|---|---|
|
Double-Blind Phase
Randomized but not Treated
|
3
|
2
|
|
Double-Blind Phase
Adverse Event
|
4
|
14
|
|
Double-Blind Phase
Death
|
1
|
2
|
|
Double-Blind Phase
Pregnancy
|
2
|
1
|
|
Double-Blind Phase
Lack of Efficacy
|
1
|
1
|
|
Double-Blind Phase
Investigator's Discretion
|
5
|
2
|
|
Double-Blind Phase
Non-Compliance with Study Drug
|
4
|
3
|
|
Double-Blind Phase
Protocol Violation
|
4
|
3
|
|
Double-Blind Phase
Withdrew Consent
|
23
|
24
|
|
Double-Blind Phase
Lost to Follow-up
|
23
|
26
|
|
Open-Label Extension Phase
Enrolled but not Treated
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
Baseline characteristics by cohort
| Measure |
E/C/F/TAF
n=435 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=432 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=867 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
36 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
35 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
364 Participants
n=5 Participants
|
376 Participants
n=7 Participants
|
740 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
60 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
375 Participants
n=5 Participants
|
362 Participants
n=7 Participants
|
737 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
76 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
94 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
250 Participants
n=5 Participants
|
255 Participants
n=7 Participants
|
505 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
252 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
502 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
63 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
HIV-1 RNA (log10 copies/mL)
|
4.55 log10 copies/mL
STANDARD_DEVIATION 0.682 • n=5 Participants
|
4.55 log10 copies/mL
STANDARD_DEVIATION 0.674 • n=7 Participants
|
4.55 log10 copies/mL
STANDARD_DEVIATION 0.678 • n=5 Participants
|
|
HIV-1 RNA Category
≤ 100,000 copies/mL
|
331 Participants
n=5 Participants
|
336 Participants
n=7 Participants
|
667 Participants
n=5 Participants
|
|
HIV-1 RNA Category
> 100,000 to ≤ 400,000 copies/mL
|
79 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
HIV-1 RNA Category
> 400,000 copies/mL
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
CD4 Cell Count
|
437 cells/µL
STANDARD_DEVIATION 223.7 • n=5 Participants
|
426 cells/µL
STANDARD_DEVIATION 212.3 • n=7 Participants
|
432 cells/µL
STANDARD_DEVIATION 218.0 • n=5 Participants
|
|
CD4 Cell Count Category
< 50 cells/µL
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
CD4 Cell Count Category
≥ 50 to < 200 cells/µL
|
48 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
CD4 Cell Count Category
≥ 200 to < 350 cells/µL
|
103 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
CD4 Cell Count Category
≥ 350 to < 500 cells/µL
|
122 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
|
CD4 Cell Count Category
≥ 500 cells/µL
|
152 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
|
HIV Disease Status
Asymptomatic
|
402 Participants
n=5 Participants
|
406 Participants
n=7 Participants
|
808 Participants
n=5 Participants
|
|
HIV Disease Status
Symptomatic HIV Infection
|
23 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
HIV Disease Status
AIDS
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
HIV Disease Status
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Full Analysis Set: 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=435 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=432 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 48
|
93.1 percentage of participants
|
92.8 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 96 and 144Population: Full Analysis Set
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Weeks 96 and 144 were 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=435 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=432 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 Weeks 96 and 144
Week 96
|
89.2 percentage of participants
|
88.2 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144
Week 144
|
86.9 percentage of participants
|
83.1 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 48, 96. and 144Population: Full Analysis Set
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Weeks 48, 96, and 144 were 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=435 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=432 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, 96, and 144
Week 48
|
86.4 percentage of participants
|
87.3 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144
Week 96
|
84.4 percentage of participants
|
83.6 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144
Week 144
|
84.6 percentage of participants
|
80.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Participants in the Full Analysis Set with on-treatment data were analyzed.
Outcome measures
| Measure |
E/C/F/TAF
n=413 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=404 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
|
235 cells/µL
Standard Deviation 183.1
|
221 cells/µL
Standard Deviation 178.9
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Participants in the Full Analysis Set with on-treatment data were analyzed.
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=384 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
|
285 cells/µL
Standard Deviation 203.0
|
271 cells/µL
Standard Deviation 208.1
|
SECONDARY outcome
Timeframe: Baseline; Week 144Population: Participants in the Full Analysis Set with on-treatment data were analyzed.
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=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
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 144
|
323 cells/µL
Standard Deviation 213.1
|
310 cells/µL
Standard Deviation 207.2
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Hip DXA Analysis Set: participants who were randomized and received at least 1 dose of study drugs and had nonmissing baseline hip BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, 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=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=394 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
|
-0.865 percent change
Standard Deviation 3.2532
|
-3.200 percent change
Standard Deviation 3.1759
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, 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=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=365 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
|
-0.951 percent change
Standard Deviation 3.8633
|
-3.515 percent change
Standard Deviation 3.9451
|
SECONDARY outcome
Timeframe: Baseline; Week 144Population: Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, 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=362 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=354 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 144
|
-0.826 percent change
Standard Deviation 4.6786
|
-3.475 percent change
Standard Deviation 4.1551
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Spine DXA Analysis Set: participants who were randomized and received at least 1 dose of study drugs and had nonmissing baseline spine BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, 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=402 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=396 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
|
-1.337 percent change
Standard Deviation 3.0715
|
-2.956 percent change
Standard Deviation 3.3524
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, 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=376 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=367 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
|
-0.907 percent change
Standard Deviation 4.0039
|
-3.053 percent change
Standard Deviation 3.9539
|
SECONDARY outcome
Timeframe: Baseline; Week 144Population: Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, 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=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=352 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 144
|
-0.809 percent change
Standard Deviation 4.5041
|
-3.023 percent change
Standard Deviation 4.3122
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: Safety Analysis Set. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.
Outcome measures
| Measure |
E/C/F/TAF
n=415 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=406 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 0.110
|
0.11 mg/dL
Standard Deviation 0.116
|
SECONDARY outcome
Timeframe: Baseline; Week 96Population: Safety Analysis Set. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.
Outcome measures
| Measure |
E/C/F/TAF
n=398 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=386 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
|
0.05 mg/dL
Standard Deviation 0.109
|
0.07 mg/dL
Standard Deviation 0.132
|
SECONDARY outcome
Timeframe: Baseline; Week 144Population: Safety Analysis Set. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.
Outcome measures
| Measure |
E/C/F/TAF
n=384 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=362 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 144
|
0.04 mg/dL
Standard Deviation 0.115
|
0.08 mg/dL
Standard Deviation 0.133
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: 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=434 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=431 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 Experiencing Treatment-emergent Proteinuria Through Week 48
Grade 1
|
25.8 percentage of participants
|
32.3 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48
Grade 2
|
4.6 percentage of participants
|
4.9 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48
Grade 3
|
0 percentage of participants
|
0.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 96 weeksPopulation: 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=434 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=431 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 Experiencing Treatment-emergent Proteinuria Through Week 96
Grade 3
|
0.2 percentage of participants
|
0.2 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96
Grade 1
|
28.8 percentage of participants
|
33.9 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96
Grade 2
|
5.1 percentage of participants
|
5.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 144 weeksPopulation: 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=434 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=431 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 Experiencing Treatment-emergent Proteinuria Through Week 144
Grade 1
|
31.3 percentage of participants
|
37.1 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144
Grade 2
|
6.0 percentage of participants
|
7.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144
Grade 3
|
0.2 percentage of participants
|
0.2 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=411 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=403 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
|
6.9 percent change
Interval -23.3 to 42.1
|
51.2 percent change
Interval 3.3 to 127.1
|
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=393 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=382 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
|
11.3 percent change
Interval -20.3 to 61.5
|
75.0 percent change
Interval 9.9 to 182.6
|
SECONDARY outcome
Timeframe: Baseline; Week 144Population: 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=381 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=355 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 144
|
37.4 percent change
Interval -6.0 to 87.3
|
106.9 percent change
Interval 38.0 to 254.9
|
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=407 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 Beta-2-microglobulin to Creatinine Ratio at Week 48
|
-32.8 percent change
Interval -58.7 to 1.3
|
18.0 percent change
Interval -28.8 to 171.6
|
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=390 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=378 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
|
-33.5 percent change
Interval -60.0 to 2.0
|
32.5 percent change
Interval -27.8 to 205.6
|
SECONDARY outcome
Timeframe: Baseline; Week 144Population: 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=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=351 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 144
|
-24.6 percent change
Interval -57.5 to 13.3
|
60.4 percent change
Interval -10.4 to 318.8
|
Adverse Events
Double-Blind: E/C/F/TAF
Serious events: 73 serious events
Other events: 380 other events
Deaths: 0 deaths
Double-Blind: E/C/F/TDF
Serious events: 65 serious events
Other events: 375 other events
Deaths: 0 deaths
Open-Label: E/C/F/TAF to E/C/F/TAF
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Open-Label: E/C/F/TDF to E/C/F/TAF
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-Blind: E/C/F/TAF
n=435 participants at risk
Adverse events reported in this group occurred during the Double-Blind Phase in participants 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.
|
Double-Blind: E/C/F/TDF
n=432 participants at risk
Adverse events reported in this group occurred during the Double-Blind Phase in participants 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 to E/C/F/TAF
n=90 participants at risk
Adverse events reported in this group occurred during the Open-Label Extension Phase in participants who switched from the Double-Blind E/C/F/TAF group to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available or until Gilead Sciences terminated the study in that country.
|
Open-Label: E/C/F/TDF to E/C/F/TAF
n=94 participants at risk
Adverse events reported in this group occurred during the Open-Label Extension Phase in participants who switched from the Double-Blind E/C/F/TAF group to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available or until Gilead Sciences terminated the study in that country.
|
|---|---|---|---|---|
|
Infections and infestations
Hepatitis syphilitic
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Infected skin ulcer
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.46%
2/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Eye disorders
Retinal detachment
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.46%
2/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Proctitis
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.46%
2/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Death
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Incarcerated hernia
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Immune system disorders
Immune reconstitution inflammatory syndrome
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Abscess limb
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Acute hepatitis C
|
0.46%
2/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
1.8%
8/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.69%
3/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Atypical mycobacterial lower respiratory tract infection
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Bacterial sepsis
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Campylobacter infection
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.69%
3/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Dengue fever
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Eye infection syphilitic
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Hepatitis C
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.69%
3/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
1.1%
1/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Meningitis viral
|
0.69%
3/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Neurosyphilis
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Penile abscess
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Perirectal abscess
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Psoas abscess
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Secondary syphilis
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Shigella infection
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Soft tissue infection
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.46%
2/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.46%
2/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Kidney contusion
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Liver contusion
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic arthritis
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Uterine perforation
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.46%
2/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Prognathism
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Retrognathia
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: 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%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Castleman's disease
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: 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
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleomorphic adenoma
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.46%
2/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.69%
3/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral infarction
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Vascular headache
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Alcohol abuse
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Completed suicide
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Drug use disorder
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Homicidal ideation
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Major depression
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Substance use disorder
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Substance-induced mood disorder
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
0.92%
4/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.46%
2/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.46%
2/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Post infection glomerulonephritis
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Alcohol detoxification
|
0.00%
0/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.23%
1/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Hypovolaemic shock
|
0.23%
1/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Double-Blind: E/C/F/TAF
n=435 participants at risk
Adverse events reported in this group occurred during the Double-Blind Phase in participants 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.
|
Double-Blind: E/C/F/TDF
n=432 participants at risk
Adverse events reported in this group occurred during the Double-Blind Phase in participants 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 to E/C/F/TAF
n=90 participants at risk
Adverse events reported in this group occurred during the Open-Label Extension Phase in participants who switched from the Double-Blind E/C/F/TAF group to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available or until Gilead Sciences terminated the study in that country.
|
Open-Label: E/C/F/TDF to E/C/F/TAF
n=94 participants at risk
Adverse events reported in this group occurred during the Open-Label Extension Phase in participants who switched from the Double-Blind E/C/F/TAF group to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet until commercially available or until Gilead Sciences terminated the study in that country.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
30/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
5.6%
24/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
3.4%
15/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
5.3%
23/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.7%
112/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
24.3%
105/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
1.1%
1/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
1.1%
1/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
4.1%
18/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
6.7%
29/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.3%
23/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
4.6%
20/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.6%
20/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
5.3%
23/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
1.1%
1/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
16.8%
73/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
19.4%
84/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
2.2%
2/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
9.0%
39/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
6.0%
26/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
11.3%
49/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
10.9%
47/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
6.7%
29/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
7.2%
31/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
1.1%
1/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
9.4%
41/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
6.7%
29/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
1.1%
1/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Chlamydial infection
|
4.4%
19/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
5.1%
22/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Folliculitis
|
6.0%
26/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
3.2%
14/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
6.4%
28/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
5.8%
25/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
1.1%
1/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Gonorrhoea
|
5.1%
22/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
4.6%
20/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
2.1%
2/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
6.4%
28/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
7.4%
32/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
6.0%
26/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
5.3%
23/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
1.1%
1/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
1.1%
1/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
9.9%
43/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
5.8%
25/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Syphilis
|
12.6%
55/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
13.0%
56/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
4.4%
4/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
2.1%
2/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
21.1%
92/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
22.0%
95/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
3.3%
3/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
2.1%
2/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
15.9%
69/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
14.8%
64/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
2.2%
2/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
1.1%
1/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
46/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
8.3%
36/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.5%
50/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
14.1%
61/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
9.4%
41/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
13.2%
57/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.8%
34/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
6.0%
26/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: 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%
29/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
6.7%
29/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
6.9%
30/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
5.8%
25/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
15.9%
69/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
14.6%
63/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
7.4%
32/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
5.8%
25/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
8.5%
37/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
8.1%
35/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
10.3%
45/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
8.1%
35/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
58/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
13.0%
56/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
4.4%
4/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
1.1%
1/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.8%
34/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
5.8%
25/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
1.1%
1/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.5%
24/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
2.1%
9/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
1.1%
1/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.5%
37/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
6.2%
27/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
1.1%
1/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
5.3%
23/435 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
5.3%
23/432 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/90 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
|
1.1%
1/94 • Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days
Safety Analysis Set: 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