Trial Outcomes & Findings for SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension (NCT NCT05549726)
NCT ID: NCT05549726
Last Updated: 2026-08-26
Results Overview
Number of days participant taking biomedical prevention divided by number of days participant biomedical prevention use measured. Biomedical prevention includes PrEP tenofovir disoproxil fumarate/lamivudine (TDF/3TC) or cabotegravir long-acting injectable (CAB-LA) and PEP
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
984 participants
Primary outcome timeframe
48 weeks
Results posted on
2026-08-26
Participant Flow
Participant milestones
| Measure |
Dynamic Choice Prevention (Including CAB LA)
The Dynamic Choice Delivery Model includes integrated PrEP and PEP services at outpatient clinics, antenatal clinics, and via VHT workers in community households. CAB-LA will be integrated into the dynamic choice delivery model as an additional biomedical prevention option in a patient-centered delivery model based on the precede framework.
Cabotegravir Injectable Suspension: CAB-LA will be one of the options for the Dynamic Choice Delivery intervention arm. CAB-LA will be a choice for at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Single-dose vial containing 600 mg/3 mL (200 mg/mL) of cabotegravir is a white to light pink, free-flowing, extended-release injectable suspension. CAB-LA administration will occur at health facilities.
Dynamic Choice Delivery Model: includes integrated PrEP (including CAB-LA) and PEP services at outpatient clinics, antenatal clinics, and via VHT workers in community households. The procedures for each trial include PrEP/PEP counseling and services, choice of service location, HIV testing options, option for longer PrEP refills, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, assessment of PrEP/PEP barriers and personalized actions, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services.
|
Standard of Care
The standard of care for PEP or PrEP differs according to each country's guidelines.
Standard of Care: The standard of care differs according to country but does not routinely offer PEP or PrEP to clients seeking services, does not offer choice of service location, HIV testing option or access to medical provider mobile phone number.
|
|---|---|---|
|
Overall Study
STARTED
|
487
|
497
|
|
Overall Study
COMPLETED
|
485
|
492
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension
Baseline characteristics by cohort
| Measure |
Dynamic Choice Prevention (Including CAB LA)
n=487 Participants
The Dynamic Choice Delivery Model includes integrated PrEP and PEP services at outpatient clinics, antenatal clinics, and via VHT workers in community households. CAB-LA will be integrated into the dynamic choice delivery model as an additional biomedical prevention option in a patient-centered delivery model based on the precede framework.
Cabotegravir Injectable Suspension: CAB-LA will be one of the options for the Dynamic Choice Delivery intervention arm. CAB-LA will be a choice for at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Single-dose vial containing 600 mg/3 mL (200 mg/mL) of cabotegravir is a white to light pink, free-flowing, extended-release injectable suspension. CAB-LA administration will occur at health facilities.
Dynamic Choice Delivery Model: includes integrated PrEP (including CAB-LA) and PEP services at outpatient clinics, antenatal clinics, and via VHT workers in community households. The procedures for each trial include PrEP/PEP counseling and services, choice of service location, HIV testing options, option for longer PrEP refills, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, assessment of PrEP/PEP barriers and personalized actions, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services.
|
Standard of Care
n=497 Participants
The standard of care for PEP or PrEP differs according to each country's guidelines.
Standard of Care: The standard of care differs according to country but does not routinely offer PEP or PrEP to clients seeking services, does not offer choice of service location, HIV testing option or access to medical provider mobile phone number.
|
Total
n=984 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · 15-24
|
139 Participants
n=31 Participants
|
159 Participants
n=49 Participants
|
298 Participants
n=80 Participants
|
|
Age, Customized
Age · >=25
|
348 Participants
n=31 Participants
|
338 Participants
n=49 Participants
|
686 Participants
n=80 Participants
|
|
Sex: Female, Male
Female
|
358 Participants
n=31 Participants
|
358 Participants
n=49 Participants
|
716 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=31 Participants
|
139 Participants
n=49 Participants
|
268 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
487 Participants
n=31 Participants
|
497 Participants
n=49 Participants
|
984 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Region of Enrollment
Uganda
|
242 participants
n=31 Participants
|
239 participants
n=49 Participants
|
481 participants
n=80 Participants
|
|
Region of Enrollment
Kenya
|
245 participants
n=31 Participants
|
258 participants
n=49 Participants
|
503 participants
n=80 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Study Participants at Week 48 with data on biomedical HIV prevention coverage during follow-up of the extension
Number of days participant taking biomedical prevention divided by number of days participant biomedical prevention use measured. Biomedical prevention includes PrEP tenofovir disoproxil fumarate/lamivudine (TDF/3TC) or cabotegravir long-acting injectable (CAB-LA) and PEP
Outcome measures
| Measure |
Dynamic Choice Prevention (Including CAB LA)
n=485 Participants
The Dynamic Choice Delivery Model includes integrated PrEP and PEP services at outpatient clinics, antenatal clinics, and via VHT workers in community households. CAB-LA will be integrated into the dynamic choice delivery model as an additional biomedical prevention option in a patient-centered delivery model based on the precede framework.
Cabotegravir Injectable Suspension: CAB-LA will be one of the options for the Dynamic Choice Delivery intervention arm. CAB-LA will be a choice for at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Single-dose vial containing 600 mg/3 mL (200 mg/mL) of cabotegravir is a white to light pink, free-flowing, extended-release injectable suspension. CAB-LA administration will occur at health facilities.
Dynamic Choice Delivery Model: includes integrated PrEP (including CAB-LA) and PEP services at outpatient clinics, antenatal clinics, and via VHT workers in community households. The procedures for each trial include PrEP/PEP counseling and services, choice of service location, HIV testing options, option for longer PrEP refills, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, assessment of PrEP/PEP barriers and personalized actions, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services.
|
Standard of Care
n=492 Participants
The standard of care for PEP or PrEP differs according to each country's guidelines.
Standard of Care: The standard of care differs according to country but does not routinely offer PEP or PrEP to clients seeking services, does not offer choice of service location, HIV testing option or access to medical provider mobile phone number.
|
|---|---|---|
|
Biomedical Prevention Covered Time
|
69.7 % of days
Interval 64.9 to 74.5
|
13.3 % of days
Interval 10.2 to 16.3
|
SECONDARY outcome
Timeframe: 48 weeksHIV incidence rate: number of HIV incident infections divided by number at risk (HIV incidence per 100 person-years)
Outcome measures
| Measure |
Dynamic Choice Prevention (Including CAB LA)
n=485 Participants
The Dynamic Choice Delivery Model includes integrated PrEP and PEP services at outpatient clinics, antenatal clinics, and via VHT workers in community households. CAB-LA will be integrated into the dynamic choice delivery model as an additional biomedical prevention option in a patient-centered delivery model based on the precede framework.
Cabotegravir Injectable Suspension: CAB-LA will be one of the options for the Dynamic Choice Delivery intervention arm. CAB-LA will be a choice for at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Single-dose vial containing 600 mg/3 mL (200 mg/mL) of cabotegravir is a white to light pink, free-flowing, extended-release injectable suspension. CAB-LA administration will occur at health facilities.
Dynamic Choice Delivery Model: includes integrated PrEP (including CAB-LA) and PEP services at outpatient clinics, antenatal clinics, and via VHT workers in community households. The procedures for each trial include PrEP/PEP counseling and services, choice of service location, HIV testing options, option for longer PrEP refills, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, assessment of PrEP/PEP barriers and personalized actions, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services.
|
Standard of Care
n=486 Participants
The standard of care for PEP or PrEP differs according to each country's guidelines.
Standard of Care: The standard of care differs according to country but does not routinely offer PEP or PrEP to clients seeking services, does not offer choice of service location, HIV testing option or access to medical provider mobile phone number.
|
|---|---|---|
|
HIV Incident Infection
|
0 infections per 100 person-years
|
1.8 infections per 100 person-years
|
SECONDARY outcome
Timeframe: 48 weeks (during follow up weeks 48-96)Population: Participants in the intervention arm only were reconsented at 48 weeks for evaluation through 96 weeks. Participants in the standard of care arm discontinued the study at 48 weeks and were not analyzed for this outcome.
HIV incidence: number of HIV incident infection in intervention participants only. Participants in the intervention arm only were reconsented at 48 weeks for evaluation through 96 weeks. Participants in the standard of care discontinued the study at 48 weeks and were not analyzed for this outcome.
Outcome measures
| Measure |
Dynamic Choice Prevention (Including CAB LA)
n=442 Participants
The Dynamic Choice Delivery Model includes integrated PrEP and PEP services at outpatient clinics, antenatal clinics, and via VHT workers in community households. CAB-LA will be integrated into the dynamic choice delivery model as an additional biomedical prevention option in a patient-centered delivery model based on the precede framework.
Cabotegravir Injectable Suspension: CAB-LA will be one of the options for the Dynamic Choice Delivery intervention arm. CAB-LA will be a choice for at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Single-dose vial containing 600 mg/3 mL (200 mg/mL) of cabotegravir is a white to light pink, free-flowing, extended-release injectable suspension. CAB-LA administration will occur at health facilities.
Dynamic Choice Delivery Model: includes integrated PrEP (including CAB-LA) and PEP services at outpatient clinics, antenatal clinics, and via VHT workers in community households. The procedures for each trial include PrEP/PEP counseling and services, choice of service location, HIV testing options, option for longer PrEP refills, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, assessment of PrEP/PEP barriers and personalized actions, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services.
|
Standard of Care
The standard of care for PEP or PrEP differs according to each country's guidelines.
Standard of Care: The standard of care differs according to country but does not routinely offer PEP or PrEP to clients seeking services, does not offer choice of service location, HIV testing option or access to medical provider mobile phone number.
|
|---|---|---|
|
HIV Incident Infection
|
1 participant
|
—
|
SECONDARY outcome
Timeframe: 48 weeks (during follow-up weeks 48-96)Population: Participants in the intervention arm only were reconsented at 48 weeks for evaluation through 96 weeks. Participants in the standard of care arm discontinued the study at 48 weeks and were not analyzed for this outcome.
Number of days participant was taking biomedical prevention divided by number of days participant had biomedical prevention use measured and self-assessed with HIV risk (intervention participants only). Participants in the intervention arm only were reconsented at 48 weeks for evaluation through 96 weeks. Participants in the standard of care discontinued the study at 48 weeks and were not analyzed for this outcome.
Outcome measures
| Measure |
Dynamic Choice Prevention (Including CAB LA)
n=442 Participants
The Dynamic Choice Delivery Model includes integrated PrEP and PEP services at outpatient clinics, antenatal clinics, and via VHT workers in community households. CAB-LA will be integrated into the dynamic choice delivery model as an additional biomedical prevention option in a patient-centered delivery model based on the precede framework.
Cabotegravir Injectable Suspension: CAB-LA will be one of the options for the Dynamic Choice Delivery intervention arm. CAB-LA will be a choice for at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Single-dose vial containing 600 mg/3 mL (200 mg/mL) of cabotegravir is a white to light pink, free-flowing, extended-release injectable suspension. CAB-LA administration will occur at health facilities.
Dynamic Choice Delivery Model: includes integrated PrEP (including CAB-LA) and PEP services at outpatient clinics, antenatal clinics, and via VHT workers in community households. The procedures for each trial include PrEP/PEP counseling and services, choice of service location, HIV testing options, option for longer PrEP refills, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, assessment of PrEP/PEP barriers and personalized actions, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services.
|
Standard of Care
The standard of care for PEP or PrEP differs according to each country's guidelines.
Standard of Care: The standard of care differs according to country but does not routinely offer PEP or PrEP to clients seeking services, does not offer choice of service location, HIV testing option or access to medical provider mobile phone number.
|
|---|---|---|
|
Biomedical Prevention During Periods of Self Assessed HIV Risk
|
85.1 % of days
Interval 0.0 to 100.0
|
—
|
Adverse Events
Dynamic Choice Prevention (Including CAB LA)
Serious events: 4 serious events
Other events: 0 other events
Deaths: 1 deaths
Standard of Care
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Dynamic Choice Prevention (Including CAB LA)
n=487 participants at risk
The Dynamic Choice Delivery Model includes integrated PrEP and PEP services at outpatient clinics, antenatal clinics, and via VHT workers in community households. CAB-LA will be integrated into the dynamic choice delivery model as an additional biomedical prevention option in a patient-centered delivery model based on the precede framework.
Cabotegravir Injectable Suspension: CAB-LA will be one of the options for the Dynamic Choice Delivery intervention arm. CAB-LA will be a choice for at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Single-dose vial containing 600 mg/3 mL (200 mg/mL) of cabotegravir is a white to light pink, free-flowing, extended-release injectable suspension. CAB-LA administration will occur at health facilities.
Dynamic Choice Delivery Model: includes integrated PrEP (including CAB-LA) and PEP services at outpatient clinics, antenatal clinics, and via VHT workers in community households. The procedures for each trial include PrEP/PEP counseling and services, choice of service location, HIV testing options, option for longer PrEP refills, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, assessment of PrEP/PEP barriers and personalized actions, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services.
|
Standard of Care
n=497 participants at risk
The standard of care for PEP or PrEP differs according to each country's guidelines.
Standard of Care: The standard of care differs according to country but does not routinely offer PEP or PrEP to clients seeking services, does not offer choice of service location, HIV testing option or access to medical provider mobile phone number.
|
|---|---|---|
|
Eye disorders
Ocular injury
|
0.21%
1/487 • Number of events 1 • Adverse events were collected in both control and intervention arms over 48 weeks. Control participants discontinued after Week 48 and adverse events were collected in intervention arm participants only from 48-96 weeks.
AEs were captured and classified using NIAID Adverse Event Grading of Severity scale. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAEs regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA. AEs were collected in control arm from 0-48 weeks and in intervention arm from 0-96 weeks.
|
0.00%
0/497 • Adverse events were collected in both control and intervention arms over 48 weeks. Control participants discontinued after Week 48 and adverse events were collected in intervention arm participants only from 48-96 weeks.
AEs were captured and classified using NIAID Adverse Event Grading of Severity scale. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAEs regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA. AEs were collected in control arm from 0-48 weeks and in intervention arm from 0-96 weeks.
|
|
Injury, poisoning and procedural complications
Hospitalization due to physical altercation
|
0.41%
2/487 • Number of events 2 • Adverse events were collected in both control and intervention arms over 48 weeks. Control participants discontinued after Week 48 and adverse events were collected in intervention arm participants only from 48-96 weeks.
AEs were captured and classified using NIAID Adverse Event Grading of Severity scale. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAEs regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA. AEs were collected in control arm from 0-48 weeks and in intervention arm from 0-96 weeks.
|
0.00%
0/497 • Adverse events were collected in both control and intervention arms over 48 weeks. Control participants discontinued after Week 48 and adverse events were collected in intervention arm participants only from 48-96 weeks.
AEs were captured and classified using NIAID Adverse Event Grading of Severity scale. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAEs regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA. AEs were collected in control arm from 0-48 weeks and in intervention arm from 0-96 weeks.
|
|
Pregnancy, puerperium and perinatal conditions
Premature birth and deaths of twins
|
0.21%
1/487 • Number of events 1 • Adverse events were collected in both control and intervention arms over 48 weeks. Control participants discontinued after Week 48 and adverse events were collected in intervention arm participants only from 48-96 weeks.
AEs were captured and classified using NIAID Adverse Event Grading of Severity scale. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAEs regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA. AEs were collected in control arm from 0-48 weeks and in intervention arm from 0-96 weeks.
|
0.00%
0/497 • Adverse events were collected in both control and intervention arms over 48 weeks. Control participants discontinued after Week 48 and adverse events were collected in intervention arm participants only from 48-96 weeks.
AEs were captured and classified using NIAID Adverse Event Grading of Severity scale. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAEs regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA. AEs were collected in control arm from 0-48 weeks and in intervention arm from 0-96 weeks.
|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage following blunt abdominal trauma
|
0.21%
1/487 • Number of events 1 • Adverse events were collected in both control and intervention arms over 48 weeks. Control participants discontinued after Week 48 and adverse events were collected in intervention arm participants only from 48-96 weeks.
AEs were captured and classified using NIAID Adverse Event Grading of Severity scale. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAEs regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA. AEs were collected in control arm from 0-48 weeks and in intervention arm from 0-96 weeks.
|
0.00%
0/497 • Adverse events were collected in both control and intervention arms over 48 weeks. Control participants discontinued after Week 48 and adverse events were collected in intervention arm participants only from 48-96 weeks.
AEs were captured and classified using NIAID Adverse Event Grading of Severity scale. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAEs regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA. AEs were collected in control arm from 0-48 weeks and in intervention arm from 0-96 weeks.
|
|
Injury, poisoning and procedural complications
Death due to motorcycle accident
|
0.00%
0/487 • Adverse events were collected in both control and intervention arms over 48 weeks. Control participants discontinued after Week 48 and adverse events were collected in intervention arm participants only from 48-96 weeks.
AEs were captured and classified using NIAID Adverse Event Grading of Severity scale. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAEs regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA. AEs were collected in control arm from 0-48 weeks and in intervention arm from 0-96 weeks.
|
0.20%
1/497 • Number of events 1 • Adverse events were collected in both control and intervention arms over 48 weeks. Control participants discontinued after Week 48 and adverse events were collected in intervention arm participants only from 48-96 weeks.
AEs were captured and classified using NIAID Adverse Event Grading of Severity scale. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAEs regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA. AEs were collected in control arm from 0-48 weeks and in intervention arm from 0-96 weeks.
|
|
General disorders
Death due to unknown causes
|
0.00%
0/487 • Adverse events were collected in both control and intervention arms over 48 weeks. Control participants discontinued after Week 48 and adverse events were collected in intervention arm participants only from 48-96 weeks.
AEs were captured and classified using NIAID Adverse Event Grading of Severity scale. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAEs regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA. AEs were collected in control arm from 0-48 weeks and in intervention arm from 0-96 weeks.
|
0.20%
1/497 • Number of events 1 • Adverse events were collected in both control and intervention arms over 48 weeks. Control participants discontinued after Week 48 and adverse events were collected in intervention arm participants only from 48-96 weeks.
AEs were captured and classified using NIAID Adverse Event Grading of Severity scale. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAEs regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA. AEs were collected in control arm from 0-48 weeks and in intervention arm from 0-96 weeks.
|
|
Cardiac disorders
Death due to likely sudden cardiac arrest
|
0.21%
1/487 • Number of events 1 • Adverse events were collected in both control and intervention arms over 48 weeks. Control participants discontinued after Week 48 and adverse events were collected in intervention arm participants only from 48-96 weeks.
AEs were captured and classified using NIAID Adverse Event Grading of Severity scale. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAEs regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA. AEs were collected in control arm from 0-48 weeks and in intervention arm from 0-96 weeks.
|
0.00%
0/497 • Adverse events were collected in both control and intervention arms over 48 weeks. Control participants discontinued after Week 48 and adverse events were collected in intervention arm participants only from 48-96 weeks.
AEs were captured and classified using NIAID Adverse Event Grading of Severity scale. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAEs regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA. AEs were collected in control arm from 0-48 weeks and in intervention arm from 0-96 weeks.
|
|
Reproductive system and breast disorders
Hospitalization for ovarian cystectomy surgery
|
0.21%
1/487 • Number of events 1 • Adverse events were collected in both control and intervention arms over 48 weeks. Control participants discontinued after Week 48 and adverse events were collected in intervention arm participants only from 48-96 weeks.
AEs were captured and classified using NIAID Adverse Event Grading of Severity scale. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAEs regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA. AEs were collected in control arm from 0-48 weeks and in intervention arm from 0-96 weeks.
|
0.00%
0/497 • Adverse events were collected in both control and intervention arms over 48 weeks. Control participants discontinued after Week 48 and adverse events were collected in intervention arm participants only from 48-96 weeks.
AEs were captured and classified using NIAID Adverse Event Grading of Severity scale. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAEs regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA. AEs were collected in control arm from 0-48 weeks and in intervention arm from 0-96 weeks.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place