Trial Outcomes & Findings for Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022) (NCT NCT04644029)
NCT ID: NCT04644029
Last Updated: 2026-02-04
Results Overview
Incidence rate per year of confirmed HIV-1 infections is the number of participants with confirmed HIV-1 infections during the assessment period divided by the number of person-years in the arm. Data are based on participants with confirmed HIV-1 infection. The originally planned primary statistical analysis was removed via amendment when open-label treatment was initiated.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
730 participants
Primary outcome timeframe
Up to approximately 325 days
Results posted on
2026-02-04
Participant Flow
One person mistakenly received study drug without being randomized. They are not included in Participant Flow or Baseline Characteristics because they were not enrolled in the study, but their adverse events are reported in the Adverse Events module because they received study drug.
Participant milestones
| Measure |
ISL QM
ISL (islatravir) once monthly AND placebo to FTC/TDF (emtricitabine/tenofovir disoproxil) once daily. Following study-wide cessation of ISL administration, participants had the option to receive open-label FTC/TDF. Placebo was no longer administered once open label treatment began.
|
FTC/TDF QD
FTC/TDF (TRUVADA™ or generic product emtricitabine/tenofovir disoproxil) administered once daily. Placebo to ISL (islatravir) administered once monthly. Following study-wide cessation of ISL administration, participants had the option to continue on open-label FTC/TDF. Placebo was no longer administered once open label treatment began.
|
|---|---|---|
|
Overall Study
STARTED
|
364
|
366
|
|
Overall Study
Treated Per Protocol Arm Design
|
362
|
365
|
|
Overall Study
Received Open-Label FTC/TDF
|
343
|
345
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
364
|
366
|
Reasons for withdrawal
| Measure |
ISL QM
ISL (islatravir) once monthly AND placebo to FTC/TDF (emtricitabine/tenofovir disoproxil) once daily. Following study-wide cessation of ISL administration, participants had the option to receive open-label FTC/TDF. Placebo was no longer administered once open label treatment began.
|
FTC/TDF QD
FTC/TDF (TRUVADA™ or generic product emtricitabine/tenofovir disoproxil) administered once daily. Placebo to ISL (islatravir) administered once monthly. Following study-wide cessation of ISL administration, participants had the option to continue on open-label FTC/TDF. Placebo was no longer administered once open label treatment began.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
21
|
19
|
|
Overall Study
Lost to Follow-up
|
31
|
34
|
|
Overall Study
Study Terminated by Sponsor
|
308
|
309
|
|
Overall Study
Randomized in Error
|
2
|
1
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)
Baseline characteristics by cohort
| Measure |
ISL QM
n=362 Participants
ISL (islatravir) once monthly AND placebo to FTC/TDF (emtricitabine/tenofovir disoproxil) once daily. Following study-wide cessation of ISL administration, participants had the option to receive open-label FTC/TDF. Placebo was no longer administered once open label treatment began.
|
FTC/TDF QD
n=365 Participants
FTC/TDF (TRUVADA™ or generic product emtricitabine/tenofovir disoproxil) administered once daily. Placebo to ISL (islatravir) administered once monthly. Following study-wide cessation of ISL administration, participants had the option to continue on open-label FTC/TDF. Placebo was no longer administered once open label treatment began.
|
Total
n=727 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.0 Years
STANDARD_DEVIATION 6.1 • n=25 Participants
|
26.1 Years
STANDARD_DEVIATION 6.3 • n=26 Participants
|
26.1 Years
STANDARD_DEVIATION 6.2 • n=51 Participants
|
|
Sex: Female, Male
Female
|
362 Participants
n=25 Participants
|
365 Participants
n=26 Participants
|
727 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=25 Participants
|
13 Participants
n=26 Participants
|
24 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
329 Participants
n=25 Participants
|
330 Participants
n=26 Participants
|
659 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=25 Participants
|
22 Participants
n=26 Participants
|
44 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=25 Participants
|
1 Participants
n=26 Participants
|
2 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=25 Participants
|
6 Participants
n=26 Participants
|
11 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
334 Participants
n=25 Participants
|
338 Participants
n=26 Participants
|
672 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=25 Participants
|
15 Participants
n=26 Participants
|
34 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=25 Participants
|
4 Participants
n=26 Participants
|
7 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
1 Participants
n=26 Participants
|
1 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 325 daysPopulation: The analysis population includes all participants who were randomized and received at least 1 dose of study intervention and did not have confirmed HIV-1 infections prior to or at randomization.
Incidence rate per year of confirmed HIV-1 infections is the number of participants with confirmed HIV-1 infections during the assessment period divided by the number of person-years in the arm. Data are based on participants with confirmed HIV-1 infection. The originally planned primary statistical analysis was removed via amendment when open-label treatment was initiated.
Outcome measures
| Measure |
ISL QM
n=362 Participants
ISL (islatravir) once monthly AND placebo to FTC/TDF (emtricitabine/tenofovir disoproxil) once daily. Following study-wide cessation of ISL administration, participants had the option to receive open-label FTC/TDF. Placebo was no longer administered once open label treatment began.
|
FTC/TDF QD
n=363 Participants
FTC/TDF (TRUVADA™ or generic product emtricitabine/tenofovir disoproxil) administered once daily. Placebo to ISL (islatravir) administered once monthly. Following study-wide cessation of ISL administration, participants had the option to continue on open-label FTC/TDF. Placebo was no longer administered once open label treatment began.
|
|---|---|---|
|
Incidence Rate Per Year of Confirmed HIV-1 Infection Among Participants During Blinded Treatment +42 Days Post-Blind
|
0.000 Percentage of Participants/Person-Year
|
0.000 Percentage of Participants/Person-Year
|
PRIMARY outcome
Timeframe: Up to approximately 325 daysPopulation: The analysis population includes all participants who were randomized and received at least 1 dose of study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced an AE will be reported for each treatment arm.
Outcome measures
| Measure |
ISL QM
n=362 Participants
ISL (islatravir) once monthly AND placebo to FTC/TDF (emtricitabine/tenofovir disoproxil) once daily. Following study-wide cessation of ISL administration, participants had the option to receive open-label FTC/TDF. Placebo was no longer administered once open label treatment began.
|
FTC/TDF QD
n=365 Participants
FTC/TDF (TRUVADA™ or generic product emtricitabine/tenofovir disoproxil) administered once daily. Placebo to ISL (islatravir) administered once monthly. Following study-wide cessation of ISL administration, participants had the option to continue on open-label FTC/TDF. Placebo was no longer administered once open label treatment began.
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE) During Blinded Treatment + 42 Days Post-Blind
|
198 Participants
|
255 Participants
|
PRIMARY outcome
Timeframe: Up to 283 daysPopulation: The analysis population includes all participants who were randomized and received at least 1 dose of study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued blinded study treatment due to an AE will be reported for each treatment arm.
Outcome measures
| Measure |
ISL QM
n=362 Participants
ISL (islatravir) once monthly AND placebo to FTC/TDF (emtricitabine/tenofovir disoproxil) once daily. Following study-wide cessation of ISL administration, participants had the option to receive open-label FTC/TDF. Placebo was no longer administered once open label treatment began.
|
FTC/TDF QD
n=365 Participants
FTC/TDF (TRUVADA™ or generic product emtricitabine/tenofovir disoproxil) administered once daily. Placebo to ISL (islatravir) administered once monthly. Following study-wide cessation of ISL administration, participants had the option to continue on open-label FTC/TDF. Placebo was no longer administered once open label treatment began.
|
|---|---|---|
|
Number of Participants Who Discontinued Blinded Study Treatment Due to an AE
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 237 daysPopulation: The analysis population includes all participants who were randomized and received at least 1 dose of ISL and did not have confirmed HIV-1 infections prior to or at randomization.
Incidence rate per year of confirmed HIV-1 infections is the number of participants with confirmed HIV-1 infections during the assessment period divided by the number of person-years in the arm. Data are based on participants with confirmed HIV-1 infection. The originally planned secondary statistical analysis was removed via amendment when open-label treatment was initiated.
Outcome measures
| Measure |
ISL QM
n=362 Participants
ISL (islatravir) once monthly AND placebo to FTC/TDF (emtricitabine/tenofovir disoproxil) once daily. Following study-wide cessation of ISL administration, participants had the option to receive open-label FTC/TDF. Placebo was no longer administered once open label treatment began.
|
FTC/TDF QD
FTC/TDF (TRUVADA™ or generic product emtricitabine/tenofovir disoproxil) administered once daily. Placebo to ISL (islatravir) administered once monthly. Following study-wide cessation of ISL administration, participants had the option to continue on open-label FTC/TDF. Placebo was no longer administered once open label treatment began.
|
|---|---|---|
|
Incidence Rate Per Year During Blinded Treatment of Confirmed HIV-1 Infection Among ISL-Treated Participants
|
0.000 Percentage of Participants/Person-Year
|
—
|
Adverse Events
ISL QM
Serious events: 4 serious events
Other events: 145 other events
Deaths: 1 deaths
ISL QM > Open-Label FTC/TDF
Serious events: 13 serious events
Other events: 292 other events
Deaths: 0 deaths
FTC/TDF QD
Serious events: 2 serious events
Other events: 210 other events
Deaths: 0 deaths
FTC/TDF > Open-Label FTC/TDF Second Course
Serious events: 23 serious events
Other events: 284 other events
Deaths: 0 deaths
FTC/TDF-Treated Without Randomization
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ISL QM
n=362 participants at risk
ISL (islatravir) once monthly AND placebo to FTC/TDF (emtricitabine/tenofovir disoproxil) once daily. Following study-wide cessation of ISL administration, participants had the option to receive open-label FTC/TDF administered once daily. Adverse events during the open-label period are not counted in this arm.
|
ISL QM > Open-Label FTC/TDF
n=343 participants at risk
This arm represents participants who received open-label FTC/TDF (TRUVADA™ or generic product emtricitabine/tenofovir disoproxil) administered once daily, after previously receiving ISL QM during the blinded portion of the study.
|
FTC/TDF QD
n=365 participants at risk
FTC/TDF (TRUVADA™ or generic product emtricitabine/tenofovir disoproxil) administered once daily. Placebo to ISL (islatravir) administered once monthly. Following study-wide cessation of ISL administration, participants had the option to continue on open-label FTC/TDF. Placebo was no longer administered once open label treatment began. Adverse events during the open-label period are not counted in this arm.
|
FTC/TDF > Open-Label FTC/TDF Second Course
n=345 participants at risk
This arm represents participants who received open-label FTC/TDF (TRUVADA™ or generic product emtricitabine/tenofovir disoproxil) administered once daily, after previously receiving FTC/TDF QD during the blinded portion of the study.
|
FTC/TDF-Treated Without Randomization
n=1 participants at risk
The participant in this arm was mistakenly given daily FTC/TDF plus monthly placebo to ISL without completing enrollment and randomization. Following study unblinding, participant continued to receive open-label daily FTC/TDF. Adverse events were collected for this participant during blinded and open-label treatment due to receiving study drug, but zero participants are reported as affected and zero adverse event instances are reported due to the risk of identification of a person.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia of pregnancy
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/343 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 3 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.27%
1/365 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.28%
1/362 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Injury, poisoning and procedural complications
Crush injury
|
0.28%
1/362 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.28%
1/362 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Investigations
Alanine aminotransferase increased
|
0.28%
1/362 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/343 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/343 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/343 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/343 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/343 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Nervous system disorders
Migraine
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Nervous system disorders
Seizure
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Nervous system disorders
Syncope
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/343 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.58%
2/343 • Number of events 2 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.27%
1/365 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
1.2%
4/345 • Number of events 4 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.28%
1/362 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/343 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Pregnancy, puerperium and perinatal conditions
Failed trial of labour
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged labour
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.58%
2/345 • Number of events 2 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous rupture of membranes
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/343 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/343 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.28%
1/362 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/343 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.27%
1/365 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Pregnancy, puerperium and perinatal conditions
HELLP syndrome
|
0.28%
1/362 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/345 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/343 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/365 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.29%
1/345 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
Other adverse events
| Measure |
ISL QM
n=362 participants at risk
ISL (islatravir) once monthly AND placebo to FTC/TDF (emtricitabine/tenofovir disoproxil) once daily. Following study-wide cessation of ISL administration, participants had the option to receive open-label FTC/TDF administered once daily. Adverse events during the open-label period are not counted in this arm.
|
ISL QM > Open-Label FTC/TDF
n=343 participants at risk
This arm represents participants who received open-label FTC/TDF (TRUVADA™ or generic product emtricitabine/tenofovir disoproxil) administered once daily, after previously receiving ISL QM during the blinded portion of the study.
|
FTC/TDF QD
n=365 participants at risk
FTC/TDF (TRUVADA™ or generic product emtricitabine/tenofovir disoproxil) administered once daily. Placebo to ISL (islatravir) administered once monthly. Following study-wide cessation of ISL administration, participants had the option to continue on open-label FTC/TDF. Placebo was no longer administered once open label treatment began. Adverse events during the open-label period are not counted in this arm.
|
FTC/TDF > Open-Label FTC/TDF Second Course
n=345 participants at risk
This arm represents participants who received open-label FTC/TDF (TRUVADA™ or generic product emtricitabine/tenofovir disoproxil) administered once daily, after previously receiving FTC/TDF QD during the blinded portion of the study.
|
FTC/TDF-Treated Without Randomization
n=1 participants at risk
The participant in this arm was mistakenly given daily FTC/TDF plus monthly placebo to ISL without completing enrollment and randomization. Following study unblinding, participant continued to receive open-label daily FTC/TDF. Adverse events were collected for this participant during blinded and open-label treatment due to receiving study drug, but zero participants are reported as affected and zero adverse event instances are reported due to the risk of identification of a person.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
19/362 • Number of events 19 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
4.1%
14/343 • Number of events 16 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
7.9%
29/365 • Number of events 32 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
6.1%
21/345 • Number of events 23 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Gastrointestinal disorders
Nausea
|
5.2%
19/362 • Number of events 21 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
3.8%
13/343 • Number of events 16 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
11.2%
41/365 • Number of events 43 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
3.8%
13/345 • Number of events 15 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
8/362 • Number of events 9 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
4.4%
15/343 • Number of events 17 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
6.0%
22/365 • Number of events 25 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
3.5%
12/345 • Number of events 13 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
General disorders
Fatigue
|
2.8%
10/362 • Number of events 12 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
1.5%
5/343 • Number of events 8 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
5.2%
19/365 • Number of events 19 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
1.4%
5/345 • Number of events 5 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
General disorders
Influenza like illness
|
1.1%
4/362 • Number of events 4 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
13.1%
45/343 • Number of events 65 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.82%
3/365 • Number of events 3 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
11.9%
41/345 • Number of events 62 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Infections and infestations
Bacterial vaginosis
|
7.7%
28/362 • Number of events 30 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
46.1%
158/343 • Number of events 263 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
15.6%
57/365 • Number of events 59 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
41.4%
143/345 • Number of events 255 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Infections and infestations
Chlamydial infection
|
1.1%
4/362 • Number of events 4 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
16.9%
58/343 • Number of events 78 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
4.7%
17/365 • Number of events 17 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
15.9%
55/345 • Number of events 71 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Infections and infestations
Gastroenteritis
|
1.9%
7/362 • Number of events 7 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
4.7%
16/343 • Number of events 18 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
1.6%
6/365 • Number of events 6 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
5.2%
18/345 • Number of events 18 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Infections and infestations
Trichomoniasis
|
0.55%
2/362 • Number of events 2 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
8.2%
28/343 • Number of events 36 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
3.0%
11/365 • Number of events 12 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
7.0%
24/345 • Number of events 28 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
21/362 • Number of events 24 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
20.4%
70/343 • Number of events 89 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
3.3%
12/365 • Number of events 13 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
15.9%
55/345 • Number of events 74 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
9.0%
31/343 • Number of events 38 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
1.4%
5/365 • Number of events 5 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
9.9%
34/345 • Number of events 38 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
3.6%
13/362 • Number of events 13 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
33.2%
114/343 • Number of events 163 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
7.9%
29/365 • Number of events 30 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
31.6%
109/345 • Number of events 160 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/362 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
5.0%
17/343 • Number of events 22 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.27%
1/365 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
6.1%
21/345 • Number of events 25 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.28%
1/362 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
5.5%
19/343 • Number of events 20 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.82%
3/365 • Number of events 3 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
2.9%
10/345 • Number of events 11 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Investigations
Blood pressure increased
|
0.55%
2/362 • Number of events 2 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
6.1%
21/343 • Number of events 28 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
1.1%
4/365 • Number of events 5 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
5.2%
18/345 • Number of events 21 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Investigations
CD4 lymphocytes decreased
|
1.1%
4/362 • Number of events 4 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
5.2%
18/343 • Number of events 24 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
1.1%
4/365 • Number of events 4 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
4.1%
14/345 • Number of events 18 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Investigations
Creatinine renal clearance decreased
|
0.28%
1/362 • Number of events 1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
7.6%
26/343 • Number of events 36 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
1.1%
4/365 • Number of events 4 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
5.8%
20/345 • Number of events 32 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
11/362 • Number of events 11 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
4.7%
16/343 • Number of events 19 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
2.2%
8/365 • Number of events 8 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
7.2%
25/345 • Number of events 28 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Nervous system disorders
Dizziness
|
4.7%
17/362 • Number of events 17 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
3.2%
11/343 • Number of events 12 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
7.4%
27/365 • Number of events 28 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.87%
3/345 • Number of events 3 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Nervous system disorders
Headache
|
11.9%
43/362 • Number of events 50 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
17.8%
61/343 • Number of events 90 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
14.5%
53/365 • Number of events 65 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
16.2%
56/345 • Number of events 83 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
3.6%
13/362 • Number of events 16 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
9.6%
33/343 • Number of events 42 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
3.0%
11/365 • Number of events 15 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
11.3%
39/345 • Number of events 53 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.9%
7/362 • Number of events 7 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
8.7%
30/343 • Number of events 36 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
3.0%
11/365 • Number of events 12 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
8.7%
30/345 • Number of events 38 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
0.00%
0/1 • Blinded arms and mistaken treatment arm: Up to approximately 325 days Open-label arms: Up to approximately 639 days (starting 42 days after last blinded treatment; includes the time leading up to first open-label treatment)
Following sponsor decision to stop dosing blinded study treatment, all participants were offered the option to receive open-label FTC/TDF. Open-label treatment arms include all events occurring more than 42 days after a participant's final blinded treatment, even if those events occurred prior to their first open-label treatment. AEs are presented for all randomized-and-treated participants. All-Cause Mortality includes all randomized participants starting from the time of randomization.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER