Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults (NCT NCT01309243)
NCT ID: NCT01309243
Last Updated: 2015-02-25
Results Overview
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the US FDA snapshot algorithm. The snapshot algorithm defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
799 participants
Primary outcome timeframe
Week 48
Results posted on
2015-02-25
Participant Flow
Subjects were enrolled in a total of 121 study sites in North America, Europe, and Australia. The first participant was screened on 23 February 2011. The last participant observation was on 03 February 2014.
991 participants were screened.
Participant milestones
| Measure |
FTC/RPV/TDF
Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily
|
EFV/FTC/TDF
Efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
|
|---|---|---|
|
Randomized Phase Through Week 96
STARTED
|
400
|
399
|
|
Randomized Phase Through Week 96
Randomized and Treated
|
394
|
392
|
|
Randomized Phase Through Week 96
COMPLETED
|
316
|
290
|
|
Randomized Phase Through Week 96
NOT COMPLETED
|
84
|
109
|
|
Extension Phase
STARTED
|
40
|
117
|
|
Extension Phase
COMPLETED
|
34
|
117
|
|
Extension Phase
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
FTC/RPV/TDF
Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily
|
EFV/FTC/TDF
Efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
|
|---|---|---|
|
Randomized Phase Through Week 96
Randomized but not treated
|
6
|
7
|
|
Randomized Phase Through Week 96
Adverse Event
|
12
|
43
|
|
Randomized Phase Through Week 96
Death
|
0
|
1
|
|
Randomized Phase Through Week 96
Pregnancy
|
2
|
0
|
|
Randomized Phase Through Week 96
Lack of Efficacy
|
16
|
4
|
|
Randomized Phase Through Week 96
Investigators Discretion
|
3
|
6
|
|
Randomized Phase Through Week 96
Withdrew Consent
|
12
|
18
|
|
Randomized Phase Through Week 96
Lost to Follow-up
|
23
|
22
|
|
Randomized Phase Through Week 96
Subject Non-Compliance
|
9
|
7
|
|
Randomized Phase Through Week 96
Protocol Violation
|
1
|
1
|
|
Extension Phase
Lost to Follow-up
|
6
|
0
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Baseline characteristics by cohort
| Measure |
FTC/RPV/TDF
n=394 Participants
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
|
EFV/FTC/TDF
n=392 Participants
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
|
Total
n=786 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 participants
n=5 Participants
|
13 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African Heritage
|
98 participants
n=5 Participants
|
94 participants
n=7 Participants
|
192 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
266 participants
n=5 Participants
|
262 participants
n=7 Participants
|
528 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
13 participants
n=5 Participants
|
19 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
37 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
37 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
366 Participants
n=5 Participants
|
364 Participants
n=7 Participants
|
730 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
59 participants
n=5 Participants
|
75 participants
n=7 Participants
|
134 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic/Latino
|
331 participants
n=5 Participants
|
315 participants
n=7 Participants
|
646 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
262 participants
n=5 Participants
|
279 participants
n=7 Participants
|
541 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
15 participants
n=5 Participants
|
25 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
28 participants
n=5 Participants
|
20 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
25 participants
n=5 Participants
|
22 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Region of Enrollment
France
|
16 participants
n=5 Participants
|
7 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
12 participants
n=5 Participants
|
8 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
10 participants
n=5 Participants
|
3 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
HIV-1 RNA
|
4.8 log10 copies/mL
STANDARD_DEVIATION 0.65 • n=5 Participants
|
4.8 log10 copies/mL
STANDARD_DEVIATION 0.61 • n=7 Participants
|
4.8 log10 copies/mL
STANDARD_DEVIATION 0.63 • n=5 Participants
|
|
HIV-1 RNA Category
≤ 100,000 copies/mL
|
260 participants
n=5 Participants
|
250 participants
n=7 Participants
|
510 participants
n=5 Participants
|
|
HIV-1 RNA Category
> 100,000 copies/mL
|
134 participants
n=5 Participants
|
142 participants
n=7 Participants
|
276 participants
n=5 Participants
|
|
Cluster of differentiation 4 (CD4) Cell Count
|
395.7 cells/μL
STANDARD_DEVIATION 179.64 • n=5 Participants
|
385.2 cells/μL
STANDARD_DEVIATION 186.82 • n=7 Participants
|
390.5 cells/μL
STANDARD_DEVIATION 183.21 • n=5 Participants
|
|
Use of lipid-lowering agent
Yes
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Use of lipid-lowering agent
No
|
390 participants
n=5 Participants
|
391 participants
n=7 Participants
|
781 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the US FDA snapshot algorithm. The snapshot algorithm defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
Outcome measures
| Measure |
FTC/RPV/TDF
n=394 Participants
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
|
EFV/FTC/TDF
n=392 Participants
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
|
85.8 percentage of participants
|
81.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 96Population: Full Analysis Set
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the US FDA snapshot algorithm.
Outcome measures
| Measure |
FTC/RPV/TDF
n=394 Participants
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
|
EFV/FTC/TDF
n=392 Participants
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
|
77.9 percentage of participants
|
72.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Full Analysis Set with available data were analyzed; the missing = excluded method was used in which all participants with missing data were excluded from analysis.
Outcome measures
| Measure |
FTC/RPV/TDF
n=357 Participants
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
|
EFV/FTC/TDF
n=346 Participants
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
|
|---|---|---|
|
Change From Baseline in CD4 Cell Count at Week 48
|
200 cells/μL
Standard Deviation 158.6
|
191 cells/μL
Standard Deviation 144.3
|
SECONDARY outcome
Timeframe: Baseline to Week 96Population: Participants in the Full Analysis Set with available data were analyzed; the missing = excluded method was used in which all participants with missing data were excluded from analysis.
Outcome measures
| Measure |
FTC/RPV/TDF
n=327 Participants
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
|
EFV/FTC/TDF
n=319 Participants
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
|
|---|---|---|
|
Change From Baseline in CD4 Cell Count at Week 96
|
278 cells/μL
Standard Deviation 186.6
|
259 cells/μL
Standard Deviation 191.4
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.
Outcome measures
| Measure |
FTC/RPV/TDF
n=322 Participants
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
|
EFV/FTC/TDF
n=305 Participants
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
|
|---|---|---|
|
Change From Baseline in Fasting Total Cholesterol at Week 48
|
1 mg/dL
Standard Deviation 28.1
|
22 mg/dL
Standard Deviation 31.3
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.
Outcome measures
| Measure |
FTC/RPV/TDF
n=322 Participants
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
|
EFV/FTC/TDF
n=305 Participants
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
|
|---|---|---|
|
Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol at Week 48
|
2 mg/dL
Standard Deviation 8.7
|
8 mg/dL
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.
Outcome measures
| Measure |
FTC/RPV/TDF
n=322 Participants
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
|
EFV/FTC/TDF
n=303 Participants
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
|
|---|---|---|
|
Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol at Week 48
|
1 mg/dL
Standard Deviation 24.4
|
14 mg/dL
Standard Deviation 28.2
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.
Outcome measures
| Measure |
FTC/RPV/TDF
n=322 Participants
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
|
EFV/FTC/TDF
n=305 Participants
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
|
|---|---|---|
|
Change From Baseline in Fasting Triglycerides at Week 48
|
-8 mg/dL
Standard Deviation 68.9
|
8 mg/dL
Standard Deviation 103.0
|
SECONDARY outcome
Timeframe: Baseline to Week 96Population: Full Analysis Set
Participants who experienced either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed for resistance. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥ 50 copies/mL and \< 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥ 400 copies/mL after achieving HIV-1 RNA \< 50 copies/mL, or as having 2 consecutive visits with \> 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥ 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis.
Outcome measures
| Measure |
FTC/RPV/TDF
n=394 Participants
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
|
EFV/FTC/TDF
n=392 Participants
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
|
|---|---|---|
|
Development of HIV-1 Drug Resistance Through Week 96, All Participants
Baseline through Week 48
|
4.3 percentage of participants
|
0.8 percentage of participants
|
|
Development of HIV-1 Drug Resistance Through Week 96, All Participants
Week 48 through Week 96
|
1.0 percentage of participants
|
0.3 percentage of participants
|
|
Development of HIV-1 Drug Resistance Through Week 96, All Participants
Baseline through Week 96
|
5.3 percentage of participants
|
1.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 96Population: Resistance Analysis Set
Resistance Analysis Set: participants with either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥ 50 copies/mL and \< 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥ 400 copies/mL after achieving HIV-1 RNA \< 50 copies/mL, or as having 2 consecutive visits with \> 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥ 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis.
Outcome measures
| Measure |
FTC/RPV/TDF
n=24 Participants
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
|
EFV/FTC/TDF
n=9 Participants
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
|
|---|---|---|
|
Development of HIV-1 Drug Resistance Through Week 96, Participants With Viral Resistance
Baseline through Week 48
|
17 participants
|
3 participants
|
|
Development of HIV-1 Drug Resistance Through Week 96, Participants With Viral Resistance
Week 48 through Week 96
|
4 participants
|
1 participants
|
|
Development of HIV-1 Drug Resistance Through Week 96, Participants With Viral Resistance
Baseline through Week 96
|
21 participants
|
4 participants
|
Adverse Events
FTC/RPV/TDF
Serious events: 36 serious events
Other events: 300 other events
Deaths: 0 deaths
EFV/FTC/TDF
Serious events: 48 serious events
Other events: 322 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FTC/RPV/TDF
n=394 participants at risk
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
|
EFV/FTC/TDF
n=392 participants at risk
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
|
|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Cardiac disorders
Myocardial infarction
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Cardiac disorders
Tachycardia
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.51%
2/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
General disorders
Chest pain
|
0.51%
2/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
General disorders
Pyrexia
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.51%
2/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
General disorders
Non-cardiac chest pain
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Immune system disorders
Anaphylactic reaction
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Appendicitis
|
0.51%
2/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Cellulitis
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Gastroenteritis
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Neurosyphilis
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.51%
2/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Abscess limb
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Anal abscess
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Bronchitis
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Eye infection syphilitic
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Furuncle
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Gastroenteritis shigella
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Meningitis viral
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Secondary syphilis
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Sepsis
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Septic shock
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Staphylococcal infection
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Concussion
|
0.51%
2/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Craniopharyngioma
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gliosarcoma
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage 0
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular germ cell cancer
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Nervous system disorders
Convulsion
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.51%
2/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Nervous system disorders
Syncope
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Nervous system disorders
Transient ischaemic attack
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Nervous system disorders
Cerebrovascular accident
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Psychiatric disorders
Depression
|
0.51%
2/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.51%
2/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Psychiatric disorders
Suicide attempt
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.77%
3/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Psychiatric disorders
Major depression
|
0.51%
2/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Psychiatric disorders
Suicidal ideation
|
0.51%
2/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Psychiatric disorders
Bipolar I disorder
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Psychiatric disorders
Alcohol abuse
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Psychiatric disorders
Delirium tremens
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Psychiatric disorders
Mental status changes
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.51%
2/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.26%
1/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Vascular disorders
Behcet's syndrome
|
0.25%
1/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
0.00%
0/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
Other adverse events
| Measure |
FTC/RPV/TDF
n=394 participants at risk
FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
|
EFV/FTC/TDF
n=392 participants at risk
EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
17.5%
69/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
19.9%
78/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
16.5%
65/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
16.6%
65/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
20/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
5.4%
21/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Gastrointestinal disorders
Flatulence
|
6.1%
24/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
2.3%
9/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
General disorders
Fatigue
|
10.7%
42/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
13.8%
54/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
General disorders
Pyrexia
|
4.1%
16/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
5.6%
22/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
14.5%
57/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
18.4%
72/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
8.4%
33/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
9.9%
39/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Bronchitis
|
8.6%
34/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
7.4%
29/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Sinusitis
|
7.1%
28/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
4.8%
19/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Syphilis
|
6.6%
26/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
4.6%
18/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Infections and infestations
Folliculitis
|
6.9%
27/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
2.0%
8/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.5%
10/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
5.1%
20/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
28/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
5.9%
23/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
20/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
6.4%
25/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
20/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
3.3%
13/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
6.9%
27/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
23.0%
90/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
14.2%
56/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
15.6%
61/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Nervous system disorders
Somnolence
|
2.3%
9/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
7.7%
30/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Psychiatric disorders
Abnormal dreams
|
5.8%
23/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
25.8%
101/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
11.4%
45/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
15.3%
60/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Psychiatric disorders
Depression
|
8.6%
34/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
12.0%
47/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Psychiatric disorders
Anxiety
|
7.1%
28/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
9.4%
37/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.6%
38/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
6.9%
27/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.8%
23/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
3.8%
15/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
31/394 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
13.0%
51/392 • Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
Safety Analysis Set
|
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