Trial Outcomes & Findings for Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) (NCT NCT04223791)
NCT ID: NCT04223791
Last Updated: 2026-03-27
Results Overview
The Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the primary outcome measure, the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48, is presented using the Food and Drug Administration (FDA) Snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
643 participants
Primary outcome timeframe
Week 48
Results posted on
2026-03-27
Participant Flow
Adult participants living with human immunodeficiency virus-1 (HIV-1) who have been virologically suppressed for ≥3 months and receiving bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) with no history of treatment failure were enrolled.
Participant milestones
| Measure |
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Base Study (Day 1 to Week 144)
STARTED
|
322
|
321
|
|
Base Study (Day 1 to Week 144)
Treated
|
322
|
319
|
|
Base Study (Day 1 to Week 144)
COMPLETED
|
224
|
211
|
|
Base Study (Day 1 to Week 144)
NOT COMPLETED
|
98
|
110
|
|
Extension Study (Week 144 to Week 168)
STARTED
|
132
|
131
|
|
Extension Study (Week 144 to Week 168)
COMPLETED
|
10
|
2
|
|
Extension Study (Week 144 to Week 168)
NOT COMPLETED
|
122
|
129
|
Reasons for withdrawal
| Measure |
DOR/ISL
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Base Study (Day 1 to Week 144)
Death
|
2
|
0
|
|
Base Study (Day 1 to Week 144)
Lost to Follow-up
|
5
|
8
|
|
Base Study (Day 1 to Week 144)
Physician Decision
|
18
|
7
|
|
Base Study (Day 1 to Week 144)
Protocol Violation
|
0
|
1
|
|
Base Study (Day 1 to Week 144)
Sponsor Decision
|
11
|
39
|
|
Base Study (Day 1 to Week 144)
Withdrawal by Subject
|
56
|
40
|
|
Base Study (Day 1 to Week 144)
Other
|
6
|
15
|
|
Extension Study (Week 144 to Week 168)
Lost to Follow-up
|
1
|
1
|
|
Extension Study (Week 144 to Week 168)
Physician Decision
|
2
|
1
|
|
Extension Study (Week 144 to Week 168)
Sponsor Decision
|
91
|
124
|
|
Extension Study (Week 144 to Week 168)
Withdrawal by Subject
|
28
|
2
|
|
Extension Study (Week 144 to Week 168)
Other
|
0
|
1
|
Baseline Characteristics
Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)
Baseline characteristics by cohort
| Measure |
DOR/ISL
n=322 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
BIC/FTC/TAF
n=321 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
Total
n=643 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=56 Participants
|
5 Participants
n=62 Participants
|
7 Participants
n=123 Participants
|
|
Age, Continuous
|
47.6 Years
STANDARD_DEVIATION 12.6 • n=56 Participants
|
48.0 Years
STANDARD_DEVIATION 11.8 • n=62 Participants
|
47.8 Years
STANDARD_DEVIATION 12.2 • n=123 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=56 Participants
|
78 Participants
n=62 Participants
|
183 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
217 Participants
n=56 Participants
|
243 Participants
n=62 Participants
|
460 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
64 Participants
n=56 Participants
|
55 Participants
n=62 Participants
|
119 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
256 Participants
n=56 Participants
|
261 Participants
n=62 Participants
|
517 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=56 Participants
|
2 Participants
n=62 Participants
|
5 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=56 Participants
|
13 Participants
n=62 Participants
|
27 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
59 Participants
n=56 Participants
|
56 Participants
n=62 Participants
|
115 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
239 Participants
n=56 Participants
|
240 Participants
n=62 Participants
|
479 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=56 Participants
|
7 Participants
n=62 Participants
|
12 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
3 Participants
n=62 Participants
|
3 Participants
n=123 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
The Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the primary outcome measure, the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48, is presented using the Food and Drug Administration (FDA) Snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
Outcome measures
| Measure |
BIC/FTC/TAF
n=319 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=322 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Percentage of Participants With Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV-1 RNA) ≥50 Copies/mL at Week 48
HIV-1 RNA ≥50 Copies/mL
|
0.3 Percentage of Participants
|
0.6 Percentage of Participants
|
|
Percentage of Participants With Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV-1 RNA) ≥50 Copies/mL at Week 48
No Virologic Data in Window
|
5.3 Percentage of Participants
|
5.6 Percentage of Participants
|
|
Percentage of Participants With Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV-1 RNA) ≥50 Copies/mL at Week 48
HIV-1 RNA <50 Copies/mL
|
94.4 Percentage of Participants
|
93.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: All randomized participants who received ≥1 dose of study intervention. Participants were included in the treatment group corresponding to the study intervention received.
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE up to week 48 is presented.
Outcome measures
| Measure |
BIC/FTC/TAF
n=319 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=322 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Percentage of Participants With One or More Adverse Events (AEs) up to Week 48
|
74.6 Percentage of Participants
|
71.1 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: All randomized participants who received ≥1 dose of study intervention. Participants were included in the treatment group corresponding to the study intervention received.
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to an AE up to week 48 is presented.
Outcome measures
| Measure |
BIC/FTC/TAF
n=319 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=322 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 48
|
2.5 Percentage of Participants
|
2.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 96Population: The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the secondary outcome measure, percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96, is presented using the Food and Drug Administration (FDA) Snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
Outcome measures
| Measure |
BIC/FTC/TAF
n=319 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=322 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 96
HIV-1 RNA ≥50 Copies/mL
|
0.3 Percentage of Participants
|
0.6 Percentage of Participants
|
|
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 96
No Virologic Data in Window
|
8.8 Percentage of Participants
|
14.3 Percentage of Participants
|
|
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 96
HIV-1 RNA <50 Copies/mL
|
90.9 Percentage of Participants
|
85.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 144Population: The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the secondary outcome measure, percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 144, is presented using the FDA snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
Outcome measures
| Measure |
BIC/FTC/TAF
n=319 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=322 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 144
HIV-1 RNA <50 Copies/mL
|
65.5 Percentage of Participants
|
51.9 Percentage of Participants
|
|
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 144
HIV-1 RNA ≥50 Copies/mL
|
1.3 Percentage of Participants
|
0.9 Percentage of Participants
|
|
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 144
No Virologic Data in Window
|
33.2 Percentage of Participants
|
47.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 48Population: The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48, is presented using the FDA snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
Outcome measures
| Measure |
BIC/FTC/TAF
n=319 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=322 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
HIV-1 RNA <50 Copies/mL
|
94.4 Percentage of Participants
|
93.8 Percentage of Participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
No Virologic Data in Window
|
5.3 Percentage of Participants
|
5.6 Percentage of Participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
HIV-1 RNA ≥50 Copies/mL
|
0.3 Percentage of Participants
|
0.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 48Population: The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA \<40 copies/mL at Week 48, is presented using the FDA snapshot missing data approach.
Outcome measures
| Measure |
BIC/FTC/TAF
n=319 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=322 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
|
94.0 Percentage of Participants
|
93.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 96Population: The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA \<50 copies/mL at Week 96, is presented using the FDA snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
Outcome measures
| Measure |
BIC/FTC/TAF
n=319 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=322 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
HIV-1 RNA <50 copies/mL
|
90.9 Percentage of Participants
|
85.1 Percentage of Participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
No Virologic Data in Window
|
8.8 Percentage of Participants
|
14.3 Percentage of Participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
HIV-1 RNA ≥50 copies/mL
|
0.3 Percentage of Participants
|
0.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 96Population: The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA \<40 copies/mL at Week 96, is presented using the FDA snapshot missing data approach.
Outcome measures
| Measure |
BIC/FTC/TAF
n=319 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=322 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 96
|
90.9 Percentage of Participants
|
84.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 144Population: The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA \<50 copies/mL at Week 144 is presented using the FDA snapshot missing data approach. The percentage values were rounded to the nearest tenth digit.
Outcome measures
| Measure |
BIC/FTC/TAF
n=319 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=322 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 144
HIV-1 RNA <50 copies/mL
|
65.5 Percentage of Participants
|
51.9 Percentage of Participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 144
No Virologic Data in Window
|
33.2 Percentage of Participants
|
47.2 Percentage of Participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 144
HIV-1 RNA ≥50 copies/mL
|
1.3 Percentage of Participants
|
0.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 144Population: The analysis population consists of all participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the secondary outcome measure, percentage of participants with HIV-1 RNA \<40 copies/mL at Week 144, is presented using the FDA snapshot missing data approach.
Outcome measures
| Measure |
BIC/FTC/TAF
n=319 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=322 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 144
|
65.5 Percentage of Participants
|
51.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: All participants who received ≥1 dose of study intervention and had data available, including baseline data available, for CD4+ T-cell count at Week 48. Participants were included in the treatment group to which they were randomized.
Plasma CD4+ T-cell count was measured in cells/mm\^3 for baseline and 48 weeks by a central laboratory. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. The mean change from baseline in CD4+ T-cell count at week 48 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
Outcome measures
| Measure |
BIC/FTC/TAF
n=298 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=301 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Mean Change From Baseline in Cluster of Differentiation-positive (CD4+) T-cell Count at Week 48
|
40.51 cells/mm^3
Interval 20.66 to 60.36
|
-19.66 cells/mm^3
Interval -39.78 to 0.45
|
SECONDARY outcome
Timeframe: Baseline and Week 96Population: All participants who received ≥1 dose of study intervention and had data available, including baseline data available, for CD4+ T-cell count at Week 96. Participants were included in the treatment group to which they were randomized.
Plasma CD4+ T-cell count was measured in cells/mm\^3 for baseline and 96 weeks by a central laboratory. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. The mean change from baseline in CD4+ T-cell count at week 96 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
Outcome measures
| Measure |
BIC/FTC/TAF
n=290 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=273 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Mean Change From Baseline in CD4+ T-cell Count at Week 96
|
62.67 cells/mm^3
Interval 40.44 to 84.9
|
5.36 cells/mm^3
Interval -19.71 to 30.42
|
SECONDARY outcome
Timeframe: Baseline and Week 144Population: All participants who received ≥1 dose of study intervention and had data available, including baseline data available, for CD4+ T-cell count at Week 144. Participants were included in the treatment group to which they were randomized.
Plasma CD4+ T-cell count was measured in cells/mm\^3 for baseline and 144 weeks by a central laboratory. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. The mean change from baseline in CD4+ T-cell count at week 144 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
Outcome measures
| Measure |
BIC/FTC/TAF
n=213 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=170 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Mean Change From Baseline in CD4+ T-cell Count at Week 144
|
66.25 cells/mm^3
Interval 38.78 to 93.73
|
0.48 cells/mm^3
Interval -28.69 to 29.64
|
SECONDARY outcome
Timeframe: Week 48Population: Participants with data available at Week 48. Per protocol, participants who met the definition of confirmed virologic rebound (two consecutive \[2 to 4 weeks apart\] occurrences of HIV-1 RNA ≥200 copies/mL) at any time during the study or who discontinued study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation. Participants for whom available genotypic or phenotypic data showed evidence of resistance, irrespective of viral load, were also included.
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL having genotypic or phenotypic evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented.
Outcome measures
| Measure |
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=1 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Number of Participants With Viral Drug Resistance-associated Substitutions at Week 48
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 96Population: Participants with data available at Week 96. Per protocol, participants who met the definition of confirmed virologic rebound (two consecutive \[2 to 4 weeks apart\] occurrences of HIV-1 RNA ≥200 copies/mL) at any time during the study or who discontinued study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation. Participants for whom available genotypic or phenotypic data showed evidence of resistance, irrespective of viral load, were also included.
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance at week 96 is presented.
Outcome measures
| Measure |
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=2 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Number of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 144Population: Participants with data available at Week 144. Per protocol, participants who met the definition of confirmed virologic rebound (two consecutive \[2 to 4 weeks apart\] occurrences of HIV-1 RNA ≥200 copies/mL) at any time during the study or who discontinued study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation. Participants for whom available genotypic or phenotypic data showed evidence of resistance, irrespective of viral load, were also included.
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance at week 144 is presented.
Outcome measures
| Measure |
BIC/FTC/TAF
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=2 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Number of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 144
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Participants who received ≥1 dose of study intervention and were included in the treatment group corresponding to the study intervention received. The analysis population included participants with baseline and at least one postbaseline test result and had data available for this outcome measure at Week 48.
Body weight was measured and recorded at baseline and week 48. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 48 is presented.
Outcome measures
| Measure |
BIC/FTC/TAF
n=302 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=306 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 48
|
0.55 kilogram (kg)
Standard Deviation 4.40
|
0.23 kilogram (kg)
Standard Deviation 4.19
|
SECONDARY outcome
Timeframe: Baseline and Week 96Population: Participants who received ≥1 dose of study intervention and were included in the treatment group corresponding to the study intervention received. The analysis population included participants with baseline and at least one postbaseline test result and had data available for this outcome measure at Week 96.
Body weight was measured and recorded at baseline and week 96. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 96 is presented.
Outcome measures
| Measure |
BIC/FTC/TAF
n=293 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=277 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 96
|
0.72 kilogram (kg)
Standard Deviation 5.72
|
0.29 kilogram (kg)
Standard Deviation 5.33
|
SECONDARY outcome
Timeframe: Baseline and Week 144Population: Participants who received ≥1 dose of study intervention and were included in the treatment group corresponding to the study intervention received. The analysis population included participants with baseline and at least one postbaseline test result and had data available for this outcome measure at Week 144.
Body weight was measured and recorded at baseline and week 144. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 144 is presented.
Outcome measures
| Measure |
BIC/FTC/TAF
n=236 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=216 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 144
|
0.84 kilogram (kg)
Standard Deviation 6.41
|
0.63 kilogram (kg)
Standard Deviation 6.67
|
SECONDARY outcome
Timeframe: Up to approximately 55 monthsPopulation: All randomized participants who received ≥1 dose of study intervention. Participants were included in the treatment group corresponding to the study intervention received.
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced at least one or more AEs is presented. Per protocol, pregnancy-related AEs collected for enrolled participants are reported separately and are presented in the AE module.
Outcome measures
| Measure |
BIC/FTC/TAF
n=319 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=322 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Percentage of Participants With One or More AEs
|
94.4 Percentage of Participants
|
96.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to approximately 40 monthsPopulation: All randomized participants who received ≥1 dose of study intervention. Participants were included in the treatment group corresponding to the study intervention received.
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to an AE is presented. Per protocol, pregnancy-related AEs collected for enrolled participants are reported separately and are presented in the AE module.
Outcome measures
| Measure |
BIC/FTC/TAF
n=319 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL
n=322 Participants
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|
|
Percentage of Participants Who Discontinued Study Intervention Due to an AE
|
6.9 Percentage of Participants
|
22.0 Percentage of Participants
|
Adverse Events
DOR/ISL: Base Study Week 0 - Week 48
Serious events: 14 serious events
Other events: 85 other events
Deaths: 0 deaths
DOR/ISL: Base Study Week 48-Week 96
Serious events: 19 serious events
Other events: 104 other events
Deaths: 2 deaths
DOR/ISL: Base Study Week 96-Week 144
Serious events: 7 serious events
Other events: 151 other events
Deaths: 0 deaths
BIC/FTC/TAF: Base Study Week 0 - Week 48
Serious events: 16 serious events
Other events: 93 other events
Deaths: 0 deaths
BIC/FTC/TAF: Base Study Week 48 - Week 96
Serious events: 11 serious events
Other events: 86 other events
Deaths: 0 deaths
BIC/FTC/TAF: Base Study Week 96 - Week 144
Serious events: 6 serious events
Other events: 101 other events
Deaths: 0 deaths
DOR/ISL: Open-Label Extension Week 144-Week 168
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
BIC/FTC/TAF: Open-Label Extension Week 144 - Week 168
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
DOR/ISL: Post-Treatment Follow-Up
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
BIC/FTC/TAF: Post-Treatment Follow-Up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DOR/ISL: Base Study Week 0 - Week 48
n=322 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL: Base Study Week 48-Week 96
n=305 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL: Base Study Week 96-Week 144
n=266 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
BIC/FTC/TAF: Base Study Week 0 - Week 48
n=319 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
BIC/FTC/TAF: Base Study Week 48 - Week 96
n=301 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
BIC/FTC/TAF: Base Study Week 96 - Week 144
n=281 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL: Open-Label Extension Week 144-Week 168
n=132 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
BIC/FTC/TAF: Open-Label Extension Week 144 - Week 168
n=131 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL: Post-Treatment Follow-Up
n=196 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
BIC/FTC/TAF: Post-Treatment Follow-Up
n=152 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.62%
2/322 • Number of events 2 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.38%
1/266 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.31%
1/322 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/301 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.38%
1/266 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.51%
1/196 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Endocrine disorders
Goitre
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/301 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.38%
1/266 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.36%
1/281 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.31%
1/322 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Gastrointestinal disorders
Splenic artery aneurysm
|
0.31%
1/322 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.36%
1/281 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.76%
1/131 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
General disorders
Death
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
General disorders
Non-cardiac chest pain
|
0.31%
1/322 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/301 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Acute hepatitis B
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Atypical pneumonia
|
0.31%
1/322 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
COVID-19
|
0.31%
1/322 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.36%
1/281 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.31%
1/322 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/301 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.31%
1/322 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Cystitis
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Cystitis escherichia
|
0.31%
1/322 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/301 • Number of events 2 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Giardiasis
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.36%
1/281 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/301 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Neurosyphilis
|
0.31%
1/322 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.36%
1/281 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/301 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/301 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.38%
1/266 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Sepsis
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.36%
1/281 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.38%
1/266 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.38%
1/266 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.51%
1/196 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/301 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.51%
1/196 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Nervous system disorders
Brachial plexopathy
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/301 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.31%
1/322 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Nervous system disorders
Status epilepticus
|
0.31%
1/322 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Nervous system disorders
Syncope
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/301 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Nervous system disorders
Thalamic stroke
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.38%
1/266 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Psychiatric disorders
Depression
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.36%
1/281 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Psychiatric disorders
Drug abuse
|
0.31%
1/322 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.38%
1/266 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.31%
1/322 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.36%
1/281 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.31%
1/322 • Number of events 2 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.31%
1/319 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Social circumstances
Imprisonment
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Social circumstances
Substance use
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/305 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.36%
1/281 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Vascular disorders
Hypertension
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/322 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.33%
1/305 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/266 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/301 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/281 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
Other adverse events
| Measure |
DOR/ISL: Base Study Week 0 - Week 48
n=322 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL: Base Study Week 48-Week 96
n=305 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL: Base Study Week 96-Week 144
n=266 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
BIC/FTC/TAF: Base Study Week 0 - Week 48
n=319 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
BIC/FTC/TAF: Base Study Week 48 - Week 96
n=301 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
BIC/FTC/TAF: Base Study Week 96 - Week 144
n=281 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL: Open-Label Extension Week 144-Week 168
n=132 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
BIC/FTC/TAF: Open-Label Extension Week 144 - Week 168
n=131 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
DOR/ISL: Post-Treatment Follow-Up
n=196 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received a once daily (QD) fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and a placebo to BIC/FTC/TAF for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.
|
BIC/FTC/TAF: Post-Treatment Follow-Up
n=152 participants at risk
Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months with no history of treatment failure who were previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) received once daily (QD) 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to fixed dose combination (FDC) DOR/ISL for 96 weeks. At Week 144, participants who consent to enter the optional open-label study extension will continue to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
8/322 • Number of events 8 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
2.3%
7/305 • Number of events 7 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
2.6%
7/266 • Number of events 7 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
6.3%
20/319 • Number of events 21 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
2.3%
7/301 • Number of events 7 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.71%
2/281 • Number of events 2 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
1.5%
2/132 • Number of events 2 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
1.0%
2/196 • Number of events 3 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
COVID-19
|
5.9%
19/322 • Number of events 19 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
13.1%
40/305 • Number of events 42 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
12.4%
33/266 • Number of events 35 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
5.6%
18/319 • Number of events 19 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
15.0%
45/301 • Number of events 47 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
16.4%
46/281 • Number of events 47 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
1.5%
2/132 • Number of events 2 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
2.6%
5/196 • Number of events 5 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
9/322 • Number of events 11 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
3.6%
11/305 • Number of events 12 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
6.0%
16/266 • Number of events 17 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.94%
3/319 • Number of events 3 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
3.7%
11/301 • Number of events 11 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
3.6%
10/281 • Number of events 10 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.76%
1/132 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
2.3%
3/131 • Number of events 3 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
2.0%
4/196 • Number of events 7 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Investigations
CD4 lymphocytes decreased
|
0.31%
1/322 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
9.2%
28/305 • Number of events 28 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
23.7%
63/266 • Number of events 75 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
1.3%
4/301 • Number of events 4 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
10.0%
28/281 • Number of events 35 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
11.4%
15/132 • Number of events 16 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
4.6%
6/131 • Number of events 6 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Investigations
Lymphocyte count decreased
|
0.31%
1/322 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
10.5%
32/305 • Number of events 32 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
32.3%
86/266 • Number of events 108 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/319 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
2.7%
8/301 • Number of events 8 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
10.0%
28/281 • Number of events 31 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
15.9%
21/132 • Number of events 21 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
4.6%
6/131 • Number of events 6 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
16/322 • Number of events 20 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
2.6%
8/305 • Number of events 9 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
3.4%
9/266 • Number of events 10 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
6.0%
19/319 • Number of events 20 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
4.7%
14/301 • Number of events 15 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
2.8%
8/281 • Number of events 9 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.76%
1/132 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.51%
1/196 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
13/322 • Number of events 14 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
3.0%
9/305 • Number of events 11 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
3.4%
9/266 • Number of events 9 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
5.3%
17/319 • Number of events 17 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
2.0%
6/301 • Number of events 6 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
2.8%
8/281 • Number of events 8 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/132 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.76%
1/131 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.51%
1/196 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Nervous system disorders
Headache
|
8.1%
26/322 • Number of events 43 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
4.6%
14/305 • Number of events 38 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
1.1%
3/266 • Number of events 7 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
6.9%
22/319 • Number of events 22 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
2.0%
6/301 • Number of events 6 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.36%
1/281 • Number of events 2 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.76%
1/132 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/131 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.51%
1/196 • Number of events 9 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
|
Vascular disorders
Hypertension
|
1.9%
6/322 • Number of events 6 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.98%
3/305 • Number of events 3 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
1.9%
5/266 • Number of events 5 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
5.0%
16/319 • Number of events 16 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
2.0%
6/301 • Number of events 6 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
1.1%
3/281 • Number of events 3 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.76%
1/132 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.76%
1/131 • Number of events 1 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/196 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
0.00%
0/152 • Up to approximately 55 months
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. ACM \& AEs reported for base \& extension: Weeks 0-48, 48-96, 96-144 \&144-168. Per protocol, participants with specific drops in CD4+/ total lymphocyte count were monitored after treatment discontinuation \& reported as "post treatment follow up". Per protocol, pregnancy-related AEs were collected for enrolled participants \& are reported by arm that participants enrolled.
|
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