Trial Outcomes & Findings for Description of Real World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany (NCT NCT03754803)
NCT ID: NCT03754803
Last Updated: 2025-08-17
Results Overview
Virologic suppression is defined as a viral load (VL) less than (\<) 50 copies (c)/mL or, if between 50-200 c/mL, with a subsequent next available measurement \<50 c/mL (within 120 days).
Recruitment status
COMPLETED
Target enrollment
376 participants
Primary outcome timeframe
At Year 3
Results posted on
2025-08-17
Participant Flow
Under EU privacy laws, participants who withdraw consent can choose whether their data up to withdrawal may be used or must be deleted. Safety data (e.g., ADRs, SAEs) are exempt and must be retained. This resulted in a higher number of participants analyzed for the Safety Analysis Set (N = 368) compared to Effectiveness Analysis Set (N = 366).
A total of 376 participants were enrolled in the Full Analysis Set, of which 10 were excluded for various reasons, including protocol violations and participant withdrawal. The remaining 366 participants were included in the Effectiveness Analysis Set.
Participant milestones
| Measure |
Total Participants
Antiretroviral treatment (ART) naïve and pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|
|
Overall Study
STARTED
|
368
|
|
Overall Study
Effectiveness Analysis Set
|
366
|
|
Overall Study
COMPLETED
|
366
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Total Participants
Antiretroviral treatment (ART) naïve and pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total Participants
n=366 Participants
Antiretroviral treatment (ART) naïve and pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|
|
Age, Continuous
|
47.0 Years
n=366 Participants
|
|
Sex/Gender, Customized
Male
|
341 Participants
n=366 Participants
|
|
Sex/Gender, Customized
Female
|
25 Participants
n=366 Participants
|
PRIMARY outcome
Timeframe: At Year 3Population: The analysis was performed on the Effectiveness Set (ES) which includes all participants from the Full Analysis Set (FAS) except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.
Virologic suppression is defined as a viral load (VL) less than (\<) 50 copies (c)/mL or, if between 50-200 c/mL, with a subsequent next available measurement \<50 c/mL (within 120 days).
Outcome measures
| Measure |
ART-naive Participants
n=31 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
n=335 Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Suppression
HIV-RNA <50 c/mL
|
67.7 Percentage of participants
|
75.5 Percentage of participants
|
|
Percentage of Participants With Sustained Virologic Suppression
HIV-RNA 50-200 c/mL & subsequent measurement <50 c/mL
|
0 Percentage of participants
|
0.3 Percentage of participants
|
SECONDARY outcome
Timeframe: At Month 6 and years 1, 2 and 3Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.
Low level viremia is defined as a VL measurement greater than (\>) 50 - \<200 c/mL for pre-treated participants. For naive participants, a VL measurement between \>50 to \<200 c/mL after initial suppression of \<50 c/mL was evaluated.
Outcome measures
| Measure |
ART-naive Participants
n=31 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
n=335 Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Percentage of Participants With Low Level Viremia
Month 6
|
3.2 Percentage of participants
|
1.8 Percentage of participants
|
|
Percentage of Participants With Low Level Viremia
Year 1
|
3.2 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Participants With Low Level Viremia
Year 2
|
6.5 Percentage of participants
|
0.9 Percentage of participants
|
|
Percentage of Participants With Low Level Viremia
Year 3
|
3.2 Percentage of participants
|
1.8 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline until Year 3Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.
Virologic rebound is defined as 2 consecutive VL measurements \>=200 c/mL after suppression. Baseline represents the last visit before the start of therapy with DTG+3TC.
Outcome measures
| Measure |
ART-naive Participants
n=31 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
n=335 Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Percentage of Participants With Virologic Rebound
|
3.4 Percentage of participants
|
0.3 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline until Year 3Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.
The intolerability was determined at the discretion of the physician. Baseline represents the last visit before the start of therapy with DTG+3TC.
Outcome measures
| Measure |
ART-naive Participants
n=31 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
n=335 Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Percentage of Participants With Treatment Switch Due to Virologic Reasons or Due to Intolerability
Virologic reasons
|
3.2 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Participants With Treatment Switch Due to Virologic Reasons or Due to Intolerability
Intolerability
|
9.7 Percentage of participants
|
3.6 Percentage of participants
|
SECONDARY outcome
Timeframe: At years 1, 2 and 3Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal.
Participants were prompted to give an estimate of their level of adherence in a single-item question part of their self-assessment questionnaires. 0-2 missed doses, 3-4 missed doses, 5-6 missed doses, and \>6 missed doses were reported.
Outcome measures
| Measure |
ART-naive Participants
n=228 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Percentage of Participants With Missed Monthly Doses
At Year 1 - >6 Missed doses
|
1 Percentage of participants
|
—
|
|
Percentage of Participants With Missed Monthly Doses
At Year 1 - 0-2 missed doses
|
93 Percentage of participants
|
—
|
|
Percentage of Participants With Missed Monthly Doses
At Year 1 - 3-4 Missed doses
|
14 Percentage of participants
|
—
|
|
Percentage of Participants With Missed Monthly Doses
At Year 1 - 5-6 Missed doses
|
1 Percentage of participants
|
—
|
|
Percentage of Participants With Missed Monthly Doses
At Year 2 - 0-2 missed doses
|
98 Percentage of participants
|
—
|
|
Percentage of Participants With Missed Monthly Doses
At Year 2 - 3-4 Missed doses
|
1 Percentage of participants
|
—
|
|
Percentage of Participants With Missed Monthly Doses
At Year 2 - 5-6 Missed doses
|
1 Percentage of participants
|
—
|
|
Percentage of Participants With Missed Monthly Doses
At Year 2 - >6 Missed doses
|
1 Percentage of participants
|
—
|
|
Percentage of Participants With Missed Monthly Doses
At Year 3 - 0-2 missed doses
|
99 Percentage of participants
|
—
|
|
Percentage of Participants With Missed Monthly Doses
At Year 3 - 3-4 Missed doses
|
1 Percentage of participants
|
—
|
|
Percentage of Participants With Missed Monthly Doses
At Year 3 - 5-6 Missed doses
|
0 Percentage of participants
|
—
|
|
Percentage of Participants With Missed Monthly Doses
At Year 3 - >6 Missed doses
|
0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline until Year 3Population: The analysis was performed on the Safety Analysis Set, which includes all ES participants who received at least one dose, plus those excluded from ES due to withdrawal but with available safety data. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.
An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Baseline represents the last visit before the start of therapy with DTG+3TC.
Outcome measures
| Measure |
ART-naive Participants
n=31 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
n=337 Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Number of Serious Adverse Events (SAEs)
|
1 Count of events
|
78 Count of events
|
SECONDARY outcome
Timeframe: From Baseline until Year 3Population: The analysis was performed on the Safety Analysis Set, which includes all ES participants who received at least one dose, plus those excluded from ES due to withdrawal but with available safety data. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.
An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Baseline represents the last visit before the start of therapy with DTG+3TC.
Outcome measures
| Measure |
ART-naive Participants
n=31 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
n=337 Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Frequency of Serious Adverse Events
|
0.01 Events per person-years
|
0.09 Events per person-years
|
SECONDARY outcome
Timeframe: From Baseline until Year 3Population: The analysis was performed on the Safety Analysis Set, which includes all ES participants who received at least one dose, plus those excluded from ES due to withdrawal but with available safety data. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.
An ADR is defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility, i.e. the relationship cannot be ruled out. A serious ADR is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Baseline represents the last visit before the start of therapy with DTG+3TC.
Outcome measures
| Measure |
ART-naive Participants
n=31 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
n=337 Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Number of Serious and Non-serious Adverse Drug Reactions (ADRs)
Serious ADRs
|
5 Count of events
|
27 Count of events
|
|
Number of Serious and Non-serious Adverse Drug Reactions (ADRs)
Non-serious ADRs
|
5 Count of events
|
22 Count of events
|
SECONDARY outcome
Timeframe: From Baseline until Year 3Population: The analysis was performed on the Safety Analysis Set, which includes all ES participants who received at least one dose, plus those excluded from ES due to withdrawal but with available safety data. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.
Any = serious and non-serious ADRs. An ADR is defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility, i.e. the relationship cannot be ruled out. A serious ADR is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Baseline represents the last visit before the start of therapy with DTG+3TC.
Outcome measures
| Measure |
ART-naive Participants
n=31 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
n=337 Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Frequency of Any Adverse Drug Reactions
|
0.06 events per person-years
|
0.03 events per person-years
|
SECONDARY outcome
Timeframe: From Baseline until Year 3Population: The analysis was performed on the Safety Analysis Set, which includes all ES participants who received at least one dose, plus those excluded from ES due to withdrawal but with available safety data.
Baseline represents the last visit before the start of therapy with DTG+3TC.
Outcome measures
| Measure |
ART-naive Participants
n=368 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Discontinuation Rates Due to Adverse Drug Reactions
|
3.9 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline until Year 3Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.
Newly identified resistance-associated mutations, including those detected before initiating treatment with DTG+3TC and most recent HIV-RNA levels. Baseline represents the last visit before the start of therapy with DTG+3TC.
Outcome measures
| Measure |
ART-naive Participants
n=31 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
n=335 Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Percentage of Participants With VL > 50 c/mL With Emergent Resistance Mutations
|
0 Percentage of participants
|
0.3 Percentage of participants
|
SECONDARY outcome
Timeframe: At years 1, 2 and 3 compared to BaselinePopulation: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.
The following lipid parameters are presented: total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. Baseline represents the last visit before the start of therapy with DTG+3TC.
Outcome measures
| Measure |
ART-naive Participants
n=31 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
n=335 Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Change in Lipid Laboratory Values
At Year 1 - Total cholesterol
|
13.0 mg/dL
Interval -2.0 to 24.0
|
-4.0 mg/dL
Interval -21.0 to 15.0
|
|
Change in Lipid Laboratory Values
At Year 2 - Total cholesterol
|
-1.0 mg/dL
Interval -12.0 to 43.0
|
-1.0 mg/dL
Interval -22.0 to 14.0
|
|
Change in Lipid Laboratory Values
At Year 3 - Total cholesterol
|
8.5 mg/dL
Interval -9.0 to 14.0
|
-6.0 mg/dL
Interval -39.0 to 14.0
|
|
Change in Lipid Laboratory Values
At Year 1 - LDL cholesterol
|
3.5 mg/dL
Interval -10.0 to 17.0
|
0.0 mg/dL
Interval -16.0 to 16.0
|
|
Change in Lipid Laboratory Values
At Year 2 - LDL cholesterol
|
2.0 mg/dL
Interval -7.0 to 27.0
|
2.0 mg/dL
Interval -18.0 to 20.0
|
|
Change in Lipid Laboratory Values
At Year 3 - LDL cholesterol
|
8.5 mg/dL
Interval -16.5 to 19.5
|
0.0 mg/dL
Interval -28.0 to 17.4
|
|
Change in Lipid Laboratory Values
At Year 1 - HDL cholesterol
|
1.0 mg/dL
Interval -3.0 to 5.0
|
0.0 mg/dL
Interval -5.0 to 4.0
|
|
Change in Lipid Laboratory Values
At Year 2 - HDL cholesterol
|
3.0 mg/dL
Interval -2.0 to 5.0
|
0.0 mg/dL
Interval -4.0 to 5.0
|
|
Change in Lipid Laboratory Values
At Year 3 - HDL cholesterol
|
3.0 mg/dL
Interval -4.0 to 8.0
|
-1.0 mg/dL
Interval -6.0 to 4.0
|
|
Change in Lipid Laboratory Values
At Year 1 - Triglycerides
|
6.0 mg/dL
Interval -12.0 to 39.0
|
-3.0 mg/dL
Interval -43.0 to 34.5
|
|
Change in Lipid Laboratory Values
At Year 2 - Triglycerides
|
14.0 mg/dL
Interval -18.0 to 27.0
|
-6.5 mg/dL
Interval -51.0 to 33.0
|
|
Change in Lipid Laboratory Values
At Year 3 - Triglycerides
|
-16.5 mg/dL
Interval -69.0 to 47.0
|
-13.0 mg/dL
Interval -47.0 to 29.0
|
SECONDARY outcome
Timeframe: At BaselinePopulation: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. Only Pre-treated participants were included, as the instrument presents the reasons for therapy switch, which requires a previous regimen before DTG + 3TC.
The primary reasons for therapy switch are side effects of previous ART, low potential for interaction, preference of a 2-drug regime, tolerability profile of DTG+3TC, pill size, easy to take (once daily, independent of meals), patient's preference, and other. Baseline represents the last visit before the start of therapy with DTG+3TC.
Outcome measures
| Measure |
ART-naive Participants
n=335 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Percentage of Participants With Reasons for Therapy Switch to DTG+3TC
Low potential for interaction
|
14 Percentage of participants
|
—
|
|
Percentage of Participants With Reasons for Therapy Switch to DTG+3TC
Side effects of previous ART
|
39 Percentage of participants
|
—
|
|
Percentage of Participants With Reasons for Therapy Switch to DTG+3TC
Preference of a 2-drug regime
|
62 Percentage of participants
|
—
|
|
Percentage of Participants With Reasons for Therapy Switch to DTG+3TC
Tolerability profile of DTG+/3TC
|
26 Percentage of participants
|
—
|
|
Percentage of Participants With Reasons for Therapy Switch to DTG+3TC
Pill size
|
1 Percentage of participants
|
—
|
|
Percentage of Participants With Reasons for Therapy Switch to DTG+3TC
Easy to take (once daily, independent of meals)
|
21 Percentage of participants
|
—
|
|
Percentage of Participants With Reasons for Therapy Switch to DTG+3TC
Patient's preference
|
21 Percentage of participants
|
—
|
|
Percentage of Participants With Reasons for Therapy Switch to DTG+3TC
Other
|
15 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: At BaselinePopulation: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. Only ART-naive participants were included, as the instrument presents the reasons for therapy initiation, which requires no previous regimen before DTG + 3TC.
The primary reasons for therapy switch are low potential for interaction, preference of a 2-drug regime, prevention of potential long-term toxicities of other therapies, tolerability profile of DTG+3TC, easy to take (once daily, independent of meals), and other. Baseline represents the last visit before the start of therapy with DTG+3TC.
Outcome measures
| Measure |
ART-naive Participants
n=31 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Percentage of Participants With Reasons for DTG+3TC Therapy Initiation
Low potential for interaction
|
3 Percentage of participants
|
—
|
|
Percentage of Participants With Reasons for DTG+3TC Therapy Initiation
Preference of a 2-drug regime
|
45 Percentage of participants
|
—
|
|
Percentage of Participants With Reasons for DTG+3TC Therapy Initiation
Prevention of potential long-term toxicities of other therapies
|
6 Percentage of participants
|
—
|
|
Percentage of Participants With Reasons for DTG+3TC Therapy Initiation
Tolerability profile of DTG+/3TC
|
6 Percentage of participants
|
—
|
|
Percentage of Participants With Reasons for DTG+3TC Therapy Initiation
Easy to take (once daily, independent of meals)
|
16 Percentage of participants
|
—
|
|
Percentage of Participants With Reasons for DTG+3TC Therapy Initiation
Other
|
23 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: At years 1, 2 and 3 compared to BaselinePopulation: The analysis was performed on the ES, including all FAS participants except those excluded for reasons such as protocol violations or withdrawal. Only Pre-treated participants were included, as the instrument compares to prior treatment, which requires a previous regimen before DTG + 3TC. Only those who completed the HIV TSQ at the specified time points were analyzed.
The change in treatment satisfaction is based on the HIV Treatment Satisfaction questionnaire (HIV TSQ). The HIV TSQ is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience and flexibility. In treatment satisfaction score ranges from 0-60, where higher the score, greater the satisfaction with treatment. Individual item scores which included All rate score ranging from 0 (very dissatisfied, inconvenient, inflexible) to 6 (very satisfied, convenient, flexible), in case of general satisfaction, there will be 10 items which will be summed to produce a score ranging from 0 to 30, with higher the score greater the satisfaction with subscale. For lifestyle scale with 8 items which will be summed to produce a score ranging from 0 to 30, with higher the score greater the satisfaction with subscale. Baseline represents the last visit before the start of therapy with DTG+3TC.
Outcome measures
| Measure |
ART-naive Participants
n=220 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Change in Treatment Satisfaction
At Year 1
|
1.0 Scores on a scale
Interval 0.0 to 6.0
|
—
|
|
Change in Treatment Satisfaction
At Year 2
|
1.0 Scores on a scale
Interval 0.0 to 5.0
|
—
|
|
Change in Treatment Satisfaction
At Year 3
|
1.0 Scores on a scale
Interval -1.0 to 5.0
|
—
|
SECONDARY outcome
Timeframe: At years 1, 2 and 3 compared to BaselinePopulation: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations or withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status. Only participants who completed the HIV SDM questionnaire at the specified time points, were analyzed.
The change in symptom distress is based on the HIV Symptom Distress Module (SDM) questionnaire. The SDM is a 20-item self-reported tool that assesses the presence and distress of symptoms related to HIV or its treatment. It includes sub-scales for treatment satisfaction and individual satisfaction with treatment changes. The treatment satisfaction score sums all items, ranging from +30 (greater improvement) to -30 (greater deterioration). Individual item scores range from +3 (much more satisfied, convenient, flexible) to -3 (much less satisfied, convenient, flexible). General satisfaction and lifestyle scores sum all items, ranging from +15 (greater improvement) to -15 (greater deterioration). Baseline represents the last visit before the start of therapy with DTG+3TC.
Outcome measures
| Measure |
ART-naive Participants
n=6 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
n=128 Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Change in Symptom Distress
At Year 1
|
-2.0 Scores on a scale
Interval -9.0 to 2.0
|
-2.0 Scores on a scale
Interval -7.0 to 2.0
|
|
Change in Symptom Distress
At Year 2
|
3.0 Scores on a scale
Interval -3.0 to 6.0
|
0.0 Scores on a scale
Interval -6.0 to 5.0
|
|
Change in Symptom Distress
At Year 3
|
-1.0 Scores on a scale
Interval -6.0 to 1.0
|
0.0 Scores on a scale
Interval -5.0 to 5.0
|
SECONDARY outcome
Timeframe: From Baseline until Year 3Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.
Baseline represents the last visit before the start of therapy with DTG+3TC.
Outcome measures
| Measure |
ART-naive Participants
n=31 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
n=335 Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Number of HIV-RNA Monitoring Measures
|
4 measurements/year
Interval 3.5 to 4.2
|
4 measurements/year
Interval 3.5 to 4.2
|
SECONDARY outcome
Timeframe: From Baseline until Year 3Population: The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.
Baseline represents the last visit before the start of therapy with DTG+3TC.
Outcome measures
| Measure |
ART-naive Participants
n=31 Participants
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
n=335 Participants
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Percentage of Participants Referred to Another Medical Specialist
|
38.7 Percentage of participants
|
71.6 Percentage of participants
|
Adverse Events
ART-naive Participants
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Pre-treated Participants
Serious events: 78 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
ART-naive Participants
n=31 participants at risk
Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
Pre-treated Participants
n=337 participants at risk
Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.59%
2/337 • Number of events 2 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.59%
2/337 • Number of events 2 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Congenital, familial and genetic disorders
Fanconi syndrome
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Eye disorders
Macular hole
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
General disorders
Chest pain
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
General disorders
Death
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.59%
2/337 • Number of events 2 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.59%
2/337 • Number of events 2 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.89%
3/337 • Number of events 3 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
1.8%
6/337 • Number of events 6 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Investigations
Transaminases increased
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.59%
2/337 • Number of events 2 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal neoplasm
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Nervous system disorders
Syncope
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Product Issues
Device dislocation
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Psychiatric disorders
Depression
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.59%
2/337 • Number of events 2 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
3.2%
1/31 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.00%
0/337 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Renal and urinary disorders
Chronic obstructive pulmonary disease
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Renal and urinary disorders
Pulmonary thrombosis
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Social circumstances
Family stress
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Surgical and medical procedures
Cardioversion
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Vascular disorders
Haematoma
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/31 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
0.30%
1/337 • Number of events 1 • Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study. The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER